11,688 Pharmaceutical Company jobs in the United States
Senior Pharmaceutical Regulatory Affairs Manager
83701 Emmett, Idaho
$110000 Annually
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Job Description
Our client is a rapidly growing pharmaceutical company dedicated to developing innovative therapies that address unmet medical needs. We are seeking a seasoned Senior Pharmaceutical Regulatory Affairs Manager to join our team. This role is pivotal in guiding the company through the complex landscape of drug approval and lifecycle management. While the role is fully remote, you will be a key leader shaping regulatory strategies and ensuring compliance. You will be responsible for developing and implementing global regulatory strategies for product development and submission, ensuring alignment with company objectives and regulatory requirements across various health authorities worldwide. The ideal candidate will possess extensive experience in regulatory affairs within the pharmaceutical industry, with a deep understanding of drug development processes, regulatory submissions (INDs, NDAs, BLAs), and post-approval activities. You will lead a team of regulatory affairs professionals, providing strategic direction, mentorship, and oversight. Responsibilities include preparing and submitting regulatory dossiers, liaising with regulatory agencies, and assessing the regulatory implications of clinical trial designs and manufacturing changes. The ability to interpret complex regulatory guidelines, anticipate regulatory challenges, and develop proactive solutions is crucial. We are looking for a strategic thinker with exceptional communication, negotiation, and leadership skills. Your expertise will be instrumental in accelerating the approval of our life-changing medications and ensuring their continued compliance in the market. This role offers the chance to significantly impact patient access to essential medicines.
Key Responsibilities:
Key Responsibilities:
- Develop and execute global regulatory strategies for product development and lifecycle management.
- Prepare, review, and submit regulatory dossiers (e.g., INDs, NDAs, BLAs, MAAs) to health authorities.
- Serve as the primary point of contact with regulatory agencies (e.g., FDA, EMA).
- Provide strategic regulatory guidance on clinical development plans, manufacturing changes, and promotional materials.
- Assess regulatory risks and develop mitigation strategies.
- Lead and mentor the regulatory affairs team, fostering a collaborative environment.
- Ensure compliance with all applicable global regulatory requirements and guidelines.
- Monitor changes in the regulatory landscape and advise the company accordingly.
- Collaborate effectively with cross-functional teams, including R&D, clinical operations, and manufacturing.
- Contribute to the development of regulatory policies and procedures.
- Bachelor's degree in Pharmacy, Life Sciences, or a related field. Advanced degree (e.g., Master's, Ph.D., Pharm.D.) strongly preferred.
- 7+ years of experience in pharmaceutical regulatory affairs, with a significant portion in strategic planning and submissions.
- Proven experience in preparing and submitting major regulatory applications in key global markets.
- In-depth knowledge of drug development processes and regulatory requirements (e.g., ICH guidelines, FDA regulations).
- Excellent leadership, communication, negotiation, and interpersonal skills.
- Strong analytical and problem-solving abilities.
- Experience managing regulatory affairs teams is essential.
- Ability to work independently and manage multiple projects effectively in a remote setting.
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0
Director of Pharmaceutical Regulatory Affairs
23451 Virginia Beach, Virginia
$190000 Annually
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Posted 6 days ago
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Job Description
Our client, a leading pharmaceutical company dedicated to developing groundbreaking therapies, is seeking a strategic and experienced Director of Pharmaceutical Regulatory Affairs to join their team in **Virginia Beach, Virginia, US**. This critical leadership role will oversee all aspects of regulatory strategy and submissions for the company's drug development pipeline. You will be responsible for developing and implementing global regulatory strategies to ensure timely approval of new drug applications (NDAs), biologics license applications (BLAs), and other regulatory submissions across key markets, including the US (FDA), Europe (EMA), and other international territories. Key responsibilities include managing a team of regulatory affairs professionals, guiding product development teams on regulatory requirements, preparing and submitting regulatory dossiers, and serving as the primary liaison with regulatory agencies. The ideal candidate will possess a deep understanding of pharmaceutical drug development processes, regulatory guidelines, and submission requirements. Proven experience in leading successful regulatory submissions and interactions with health authorities is essential. Strong leadership, strategic thinking, and excellent communication skills are paramount. You must be adept at navigating complex regulatory landscapes, anticipating potential challenges, and developing proactive solutions. This hybrid role offers a compelling opportunity to make a significant impact on patient lives by bringing innovative medicines to market. Join a collaborative and science-driven organization committed to excellence in pharmaceutical development.
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1
Senior Pharmaceutical Regulatory Affairs Specialist
27601 Whispering Pines, North Carolina
$100000 Annually
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Posted 8 days ago
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Job Description
Our client, a rapidly growing pharmaceutical company, is seeking an experienced Senior Pharmaceutical Regulatory Affairs Specialist to join their dedicated team in **Raleigh, North Carolina**. This critical role involves ensuring that all company products comply with the complex and ever-changing regulatory landscape. You will be responsible for preparing, reviewing, and submitting regulatory documentation for drug products, liaising with regulatory agencies, and providing strategic guidance on regulatory requirements throughout the product lifecycle. The ideal candidate possesses a deep understanding of global pharmaceutical regulations and a proven track record of successfully navigating regulatory submissions.
Key Responsibilities:
The successful candidate will hold a Bachelor's degree in Pharmacy, Life Sciences, Chemistry, or a related field; an advanced degree (Master's or PhD) is preferred. A minimum of 7 years of progressive experience in pharmaceutical regulatory affairs is required, with demonstrable experience in preparing and submitting major regulatory dossiers. Comprehensive knowledge of FDA and EMA regulations is essential, and experience with other international regulatory bodies is a significant advantage. Excellent written and verbal communication skills, strong analytical and problem-solving abilities, and meticulous attention to detail are critical. You should possess strong project management skills and the ability to work effectively in a team-oriented, fast-paced environment. If you are a seasoned regulatory affairs professional looking to contribute to the development and approval of life-saving medications, we encourage you to apply.
Key Responsibilities:
- Preparing and reviewing regulatory submission documents (e.g., INDs, NDAs, MAAs) in accordance with FDA, EMA, and other global health authority requirements.
- Serving as the primary point of contact with regulatory agencies for assigned projects.
- Developing and implementing regulatory strategies for product development and approval.
- Monitoring regulatory intelligence and ensuring the company stays updated on relevant regulations and guidelines.
- Providing regulatory guidance and support to cross-functional teams, including R&D, manufacturing, and marketing.
- Conducting regulatory compliance audits and risk assessments.
- Managing post-approval regulatory activities, including labeling changes and annual reporting.
- Participating in regulatory inspections and responding to agency inquiries.
- Assisting in the development and training of junior regulatory affairs personnel.
- Contributing to the continuous improvement of regulatory processes and procedures.
The successful candidate will hold a Bachelor's degree in Pharmacy, Life Sciences, Chemistry, or a related field; an advanced degree (Master's or PhD) is preferred. A minimum of 7 years of progressive experience in pharmaceutical regulatory affairs is required, with demonstrable experience in preparing and submitting major regulatory dossiers. Comprehensive knowledge of FDA and EMA regulations is essential, and experience with other international regulatory bodies is a significant advantage. Excellent written and verbal communication skills, strong analytical and problem-solving abilities, and meticulous attention to detail are critical. You should possess strong project management skills and the ability to work effectively in a team-oriented, fast-paced environment. If you are a seasoned regulatory affairs professional looking to contribute to the development and approval of life-saving medications, we encourage you to apply.
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2
Senior Pharmaceutical Regulatory Affairs Specialist
49501 Grand Rapids, Michigan
$110000 Annually
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Posted 8 days ago
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Job Description
Our client, a leading pharmaceutical company, is seeking a highly experienced Senior Pharmaceutical Regulatory Affairs Specialist to join their team in Grand Rapids, Michigan, US . This hybrid role is critical for ensuring that the company's products comply with all relevant national and international regulatory requirements throughout their lifecycle. The ideal candidate will possess a deep understanding of pharmaceutical regulations, strong analytical skills, and the ability to navigate complex regulatory landscapes.
Responsibilities:
Responsibilities:
- Prepare, submit, and manage regulatory filings for new drug applications (NDAs), marketing authorization applications (MAAs), and post-approval changes.
- Ensure compliance with FDA, EMA, and other relevant health authority regulations.
- Interpret and advise on regulatory requirements, guidelines, and legislation impacting product development and commercialization.
- Develop and implement regulatory strategies to support product development and lifecycle management.
- Review and approve labeling, promotional materials, and advertising to ensure regulatory compliance.
- Liaise with regulatory agencies, health authorities, and internal stakeholders to facilitate the approval process.
- Monitor changes in the regulatory environment and assess their impact on the company's products and strategies.
- Conduct regulatory due diligence for potential business development opportunities and acquisitions.
- Lead and mentor junior regulatory affairs team members.
- Contribute to the development and implementation of departmental SOPs and best practices.
- Participate in cross-functional teams (e.g., R&D, Clinical, Manufacturing, Marketing) to provide regulatory input and guidance.
- Manage interactions with regulatory bodies during inspections and audits.
- Maintain up-to-date knowledge of global regulatory trends and requirements.
- Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life sciences field. Advanced degree (Master's or Pharm.D.) and/or RAC certification preferred.
- Minimum of 5-7 years of progressive experience in pharmaceutical regulatory affairs.
- Proven experience in preparing and submitting regulatory dossiers to major health authorities (FDA, EMA).
- In-depth knowledge of pharmaceutical regulations, guidelines, and submission requirements.
- Strong understanding of drug development processes, manufacturing, and quality assurance.
- Excellent analytical, problem-solving, and critical thinking skills.
- Exceptional written and verbal communication skills, with the ability to clearly articulate complex regulatory information.
- Strong project management and organizational skills.
- Ability to work effectively in a hybrid environment and collaborate with cross-functional teams.
- Experience with regulatory information management systems (RIMS) is a plus.
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3
Senior Regulatory Affairs Specialist, Pharmaceutical
23451 Virginia Beach, Virginia
$145000 Annually
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Posted 8 days ago
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Job Description
Our client, a cutting-edge biopharmaceutical company, is seeking a seasoned Senior Regulatory Affairs Specialist to join their fully remote team. This position offers the flexibility to work from anywhere in the US and will play a critical role in ensuring compliance with global regulatory requirements for drug development and submission. The successful candidate will be responsible for developing and executing regulatory strategies, preparing and submitting regulatory dossiers (e.g., INDs, NDAs, MAAs), and interfacing with regulatory agencies such as the FDA and EMA. You will provide expert guidance on regulatory pathways, labeling requirements, and post-market compliance.
The ideal candidate will possess a Bachelor's or Master's degree in a relevant scientific discipline (e.g., Pharmacy, Chemistry, Biology) and a minimum of 6-8 years of progressive experience in pharmaceutical regulatory affairs. A strong understanding of global regulatory guidelines, ICH, GMP, GCP, and GLP is essential. Proven experience in preparing and submitting regulatory filings for small molecules or biologics is required. Excellent written and verbal communication skills, with the ability to articulate complex scientific and regulatory information clearly and concisely, are crucial. You must be a self-starter, capable of managing multiple projects simultaneously and working effectively within a remote, cross-functional team environment.
This role requires a strategic thinker with a meticulous attention to detail and a deep commitment to regulatory compliance. You will collaborate closely with R&D, clinical operations, quality assurance, and manufacturing teams to ensure that regulatory requirements are met throughout the product lifecycle. The ability to anticipate regulatory challenges and develop proactive solutions is highly valued. Our client fosters a collaborative and innovative culture, providing ample opportunities for professional growth and development. This is an exceptional chance to contribute to bringing life-changing therapies to patients worldwide while enjoying the benefits of a remote work arrangement.
Key Responsibilities:
The ideal candidate will possess a Bachelor's or Master's degree in a relevant scientific discipline (e.g., Pharmacy, Chemistry, Biology) and a minimum of 6-8 years of progressive experience in pharmaceutical regulatory affairs. A strong understanding of global regulatory guidelines, ICH, GMP, GCP, and GLP is essential. Proven experience in preparing and submitting regulatory filings for small molecules or biologics is required. Excellent written and verbal communication skills, with the ability to articulate complex scientific and regulatory information clearly and concisely, are crucial. You must be a self-starter, capable of managing multiple projects simultaneously and working effectively within a remote, cross-functional team environment.
This role requires a strategic thinker with a meticulous attention to detail and a deep commitment to regulatory compliance. You will collaborate closely with R&D, clinical operations, quality assurance, and manufacturing teams to ensure that regulatory requirements are met throughout the product lifecycle. The ability to anticipate regulatory challenges and develop proactive solutions is highly valued. Our client fosters a collaborative and innovative culture, providing ample opportunities for professional growth and development. This is an exceptional chance to contribute to bringing life-changing therapies to patients worldwide while enjoying the benefits of a remote work arrangement.
Key Responsibilities:
- Develop and implement regulatory strategies for drug development programs.
- Prepare, review, and submit regulatory dossiers to health authorities globally.
- Serve as the primary point of contact with regulatory agencies.
- Interpret and apply relevant regulations, guidelines, and standards.
- Advise on labeling requirements and ensure compliance.
- Oversee post-approval regulatory activities, including lifecycle management.
- Collaborate with internal departments to ensure regulatory compliance across all functions.
- Conduct regulatory intelligence activities to stay abreast of evolving requirements.
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4
Director of Pharmaceutical Regulatory Affairs
63101 St. Louis, Missouri
$170000 Annually
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Posted 8 days ago
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Job Description
Our client, a leading Pharmaceutical company, is seeking a highly accomplished and strategically minded Director of Pharmaceutical Regulatory Affairs to join their fully remote team. This senior leadership role is paramount in ensuring compliance with global regulatory requirements for drug development, manufacturing, and marketing. The Director will oversee the preparation and submission of regulatory filings, manage interactions with health authorities, and provide expert guidance on regulatory strategies to cross-functional teams. You will play a crucial part in bringing innovative therapies to market while upholding the highest standards of quality and compliance.
Responsibilities:
Responsibilities:
- Develop and implement comprehensive regulatory strategies for product development, registration, and lifecycle management.
- Lead the preparation, submission, and approval of regulatory dossiers (e.g., INDs, NDAs, MAAs) to global health authorities (FDA, EMA, etc.).
- Serve as the primary point of contact with regulatory agencies, managing all communications and meetings.
- Provide expert interpretation of regulatory guidelines and advise project teams on compliance requirements.
- Oversee the review and approval of promotional materials, labeling, and advertising to ensure regulatory compliance.
- Monitor changes in the global regulatory landscape and proactively adapt strategies to ensure ongoing compliance.
- Manage and mentor a team of regulatory affairs professionals, fostering professional development and high performance.
- Collaborate closely with R&D, Clinical Operations, Quality Assurance, and Commercial teams to align regulatory activities with business objectives.
- Ensure that all company activities adhere to current Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Good Pharmacovigilance Practices (GVP).
- Contribute to the company's strategic planning by identifying regulatory risks and opportunities.
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5
Principal Pharmaceutical Regulatory Affairs Specialist
68101 Omaha, Nebraska
$130000 Annually
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Posted 8 days ago
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Job Description
Our client, a leading pharmaceutical innovator, is seeking a highly accomplished Principal Pharmaceutical Regulatory Affairs Specialist to lead and strategize global regulatory submissions. This is a critical, fully remote role that requires deep expertise in navigating complex international regulatory landscapes for drug development and approval. The ideal candidate will possess extensive experience in preparing and submitting regulatory dossiers to major health authorities such as the FDA, EMA, and PMDA. You will be responsible for developing and executing regulatory strategies that accelerate product development timelines while ensuring full compliance with all applicable regulations and guidelines. This includes providing expert guidance on regulatory requirements for clinical trial applications (CTAs), marketing authorization applications (MAAs), and post-approval variations. Collaboration with internal teams, including R&D, clinical operations, quality assurance, and legal, will be paramount. You will also serve as a key liaison with regulatory agencies, fostering positive and productive relationships. The role demands a proactive approach to identifying regulatory risks and opportunities, developing mitigation strategies, and staying ahead of evolving regulatory intelligence. Experience in specific therapeutic areas, such as oncology, rare diseases, or biologics, is highly advantageous. Strong analytical, problem-solving, and negotiation skills are essential. As a fully remote professional, you must demonstrate exceptional self-discipline, communication skills, and proficiency in leveraging virtual collaboration tools. You will play a pivotal role in bringing life-changing therapies to patients worldwide by ensuring efficient and effective regulatory pathways. This position offers the chance to shape regulatory strategies for a pipeline of innovative pharmaceutical products.
Responsibilities:
Responsibilities:
- Develop and implement global regulatory strategies for pharmaceutical product development and registration.
- Prepare, review, and submit regulatory dossiers (e.g., INDs, NDAs, MAAs, variations) to global health authorities.
- Provide expert guidance on regulatory requirements and strategy for clinical trials and marketing authorizations.
- Serve as the primary regulatory contact for health authorities and manage agency interactions.
- Collaborate with R&D, clinical, manufacturing, and quality teams to ensure regulatory compliance.
- Monitor and interpret evolving regulatory landscapes and provide strategic insights.
- Assess the regulatory impact of proposed changes and provide recommendations.
- Lead regulatory due diligence for potential business development opportunities.
- Mentor junior regulatory affairs professionals.
- Advanced degree (Master's or Ph.D.) in Pharmacy, Life Sciences, or a related discipline.
- 10+ years of progressive experience in pharmaceutical regulatory affairs.
- Extensive experience with FDA, EMA, and other major health authority requirements.
- Proven success in leading global regulatory submissions and achieving product approvals.
- Deep understanding of drug development processes, GMP, GCP, and GLP.
- Exceptional communication, negotiation, and interpersonal skills.
- Strong leadership and project management capabilities.
- Ability to work independently and manage complex projects in a remote setting.
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6
Senior Pharmaceutical Regulatory Affairs Manager
53701 Madison, Wisconsin
$140000 Annually
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Posted 8 days ago
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Job Description
Our client, a leading pharmaceutical company, is seeking a highly experienced Senior Pharmaceutical Regulatory Affairs Manager to join their dynamic team. This hybrid role, based in Madison, Wisconsin, US , offers a compelling blend of on-site collaboration and remote flexibility. You will be responsible for developing and executing global regulatory strategies for new drug applications and lifecycle management of approved pharmaceutical products. This includes preparing and submitting regulatory dossiers to health authorities worldwide, ensuring compliance with all applicable regulations and guidelines. Key responsibilities involve interfacing with regulatory agencies, providing regulatory guidance to cross-functional teams, and staying abreast of evolving regulatory landscapes. The ideal candidate will possess a strong scientific background (e.g., PhD, PharmD, MSc in a relevant life science field) and a minimum of 7 years of progressive experience in pharmaceutical regulatory affairs. Proven expertise in preparing and submitting INDs, NDAs, BLAs, and other regulatory submissions is essential. Excellent analytical, problem-solving, and communication skills are required for navigating complex regulatory challenges and collaborating effectively with internal teams (R&D, clinical, manufacturing) and external partners. You should have a deep understanding of GMP, GCP, and GLP regulations. This role demands a highly organized, detail-oriented, and strategic thinker committed to bringing life-saving therapies to patients efficiently and compliantly. Join our client in advancing pharmaceutical innovation through expert regulatory guidance, contributing significantly to global health in a flexible hybrid work environment.
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7
Director of Pharmaceutical Regulatory Affairs
35801 Huntsville, Alabama
$170000 Annually
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Posted 8 days ago
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Job Description
Our client, a rapidly growing pharmaceutical company at the forefront of medical innovation, is seeking a distinguished Director of Pharmaceutical Regulatory Affairs to lead their critical regulatory functions. Based in Huntsville, Alabama, US , this senior leadership role will be instrumental in guiding the company through the complex landscape of drug development and market approval. The ideal candidate possesses extensive experience with global regulatory agencies (e.g., FDA, EMA), a profound understanding of pharmaceutical development processes, and a proven track record of successfully navigating regulatory submissions and approvals. Responsibilities include developing and implementing comprehensive regulatory strategies, overseeing the preparation and submission of regulatory dossiers, ensuring compliance with all applicable regulations and guidelines, and serving as the primary liaison with health authorities. You will lead and mentor a team of regulatory affairs professionals, fostering a culture of excellence and compliance. A strong understanding of drug manufacturing, quality assurance, and clinical trial processes is essential. This position offers a hybrid work model, combining essential on-site collaboration within our Huntsville, Alabama, US facilities with remote work flexibility. We are looking for a strategic visionary who can anticipate regulatory trends, mitigate risks, and champion innovative approaches to drug development. If you are a highly accomplished regulatory affairs expert with a passion for bringing life-saving medicines to patients worldwide, we encourage you to explore this exceptional opportunity to shape the future of our company.
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8
Remote Pharmaceutical Regulatory Affairs Specialist
27513 Whispering Pines, North Carolina
$90000 Annually
WhatJobs
Posted 8 days ago
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Job Description
Our client is seeking a highly motivated and experienced Remote Pharmaceutical Regulatory Affairs Specialist to join their dynamic team. This fully remote position offers the opportunity to contribute to global drug development and registration from anywhere in the country. The specialist will be responsible for preparing, reviewing, and submitting regulatory documentation to health authorities worldwide, including the FDA, EMA, and other international agencies. You will play a crucial role in developing regulatory strategies, ensuring compliance with current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), and Good Clinical Practices (GCP). Key responsibilities include interpreting complex regulatory guidelines, advising project teams on regulatory requirements, and managing the lifecycle of regulatory submissions. The ideal candidate will possess a strong understanding of pharmaceutical drug development processes and possess excellent written and verbal communication skills, essential for crafting clear and concise regulatory submissions. You will collaborate closely with R&D, clinical, manufacturing, and quality assurance departments to ensure all regulatory aspects are addressed throughout the product lifecycle. This role demands meticulous attention to detail, strong analytical skills, and the ability to manage multiple projects concurrently in a fast-paced environment. A proven track record of successfully navigating regulatory pathways and securing approvals for new drug applications or variations is highly desirable. This is a remote-first role, requiring self-discipline, effective time management, and the ability to work independently while remaining a collaborative team member. Our client is committed to providing a supportive and flexible work environment, empowering professionals to excel in their roles. If you are a seasoned Regulatory Affairs professional looking for a challenging and rewarding remote opportunity within the pharmaceutical industry, we encourage you to apply.
Responsibilities:
Responsibilities:
- Develop and implement global regulatory strategies for pharmaceutical products.
- Prepare and submit regulatory dossiers (e.g., INDs, NDAs, MAAs) to health authorities.
- Ensure compliance with global regulatory requirements (FDA, EMA, etc.).
- Review and provide input on product development, clinical, and manufacturing documentation.
- Interpret and apply regulatory guidelines and regulations.
- Serve as a regulatory liaison with health authorities.
- Manage post-approval regulatory activities and submissions.
- Advise internal teams on regulatory requirements and implications.
- Maintain regulatory intelligence and track changes in regulations.
- Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field.
- Minimum of 5 years of experience in pharmaceutical regulatory affairs.
- In-depth knowledge of drug development processes and regulatory submission requirements.
- Experience with FDA, EMA, and other major health authority regulations.
- Excellent written and verbal communication skills.
- Strong analytical and problem-solving abilities.
- Ability to work independently and manage multiple projects effectively.
- Proficiency in regulatory information management systems is a plus.
Apply Now
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