3 Pharmaceutical Regulatory jobs in the United States
Pharmaceutical Regulatory Affairs Specialist
20004 Washington, District Of Columbia
$90000 Annually
WhatJobs
Posted 15 days ago
Job Viewed
Job Description
Our client, a leading biopharmaceutical company committed to developing innovative therapies, is seeking a highly skilled and meticulous Pharmaceutical Regulatory Affairs Specialist to join their team in Washington, D.C., US . This critical role is responsible for ensuring compliance with global regulatory requirements throughout the product lifecycle, from development and approval to post-market surveillance. The successful candidate will play a key role in preparing and submitting regulatory dossiers to health authorities.
As a Pharmaceutical Regulatory Affairs Specialist, you will be instrumental in navigating the complex regulatory landscape to bring new medicines to patients. Your responsibilities will include preparing, compiling, and submitting regulatory documents (e.g., INDs, NDAs, BLAs, MAAs, variations) to regulatory agencies such as the FDA, EMA, and other international bodies. You will interpret and apply regulatory guidelines, ensuring all submissions are accurate, complete, and compliant. A key aspect of this role involves communicating effectively with regulatory authorities, responding to their inquiries, and managing interactions. You will also collaborate closely with cross-functional teams, including R&D, clinical, manufacturing, and quality assurance, to provide regulatory guidance and ensure all activities align with regulatory strategies. We are looking for a detail-oriented professional with a strong understanding of pharmaceutical regulations, excellent writing skills, and a commitment to maintaining the highest standards of compliance and ethics.
Key Responsibilities:
As a Pharmaceutical Regulatory Affairs Specialist, you will be instrumental in navigating the complex regulatory landscape to bring new medicines to patients. Your responsibilities will include preparing, compiling, and submitting regulatory documents (e.g., INDs, NDAs, BLAs, MAAs, variations) to regulatory agencies such as the FDA, EMA, and other international bodies. You will interpret and apply regulatory guidelines, ensuring all submissions are accurate, complete, and compliant. A key aspect of this role involves communicating effectively with regulatory authorities, responding to their inquiries, and managing interactions. You will also collaborate closely with cross-functional teams, including R&D, clinical, manufacturing, and quality assurance, to provide regulatory guidance and ensure all activities align with regulatory strategies. We are looking for a detail-oriented professional with a strong understanding of pharmaceutical regulations, excellent writing skills, and a commitment to maintaining the highest standards of compliance and ethics.
Key Responsibilities:
- Prepare, compile, and submit regulatory dossiers (e.g., INDs, NDAs, BLAs, MAAs, variations) to global health authorities.
- Interpret and apply relevant regulatory guidelines, laws, and regulations (e.g., FDA, EMA, ICH).
- Manage communications and interactions with regulatory agencies.
- Provide regulatory guidance and support to internal project teams (e.g., R&D, clinical, manufacturing).
- Review and approve regulatory aspects of study protocols, reports, and labeling.
- Ensure ongoing regulatory compliance for marketed products, including annual reports and safety updates.
- Maintain current knowledge of global regulatory requirements and industry trends.
- Support regulatory inspections and audits.
- Identify potential regulatory risks and develop mitigation strategies.
- Participate in cross-functional meetings to develop regulatory strategies for new products.
- Bachelor's degree in a life science, pharmacy, or related scientific discipline.
- Minimum of 3-5 years of experience in regulatory affairs within the pharmaceutical or biotechnology industry.
- Strong knowledge of FDA regulations (21 CFR), ICH guidelines, and GxP (GCP, GLP, GMP).
- Experience with eCTD submissions and regulatory information management systems.
- Excellent written and verbal communication skills, with strong attention to detail.
- Ability to interpret complex scientific and regulatory information.
- Strong organizational skills and ability to manage multiple priorities.
- Proficiency in Microsoft Office Suite.
- Master's degree or Pharm.D.
- Experience with international regulatory submissions.
- RAC (Regulatory Affairs Certification).
- Experience with specific therapeutic areas.
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0
Regulatory Affairs Specialist (Pharmaceutical)
60601 Chicago, Illinois
$90000 Annually
WhatJobs
Posted 15 days ago
Job Viewed
Job Description
Our client, a prominent pharmaceutical company with a strong pipeline of innovative therapies, is seeking a highly skilled and diligent Regulatory Affairs Specialist to join their team in Chicago, Illinois, US . This crucial role is responsible for ensuring that all pharmaceutical products and development processes comply with the complex and evolving global regulatory landscape. The ideal candidate will possess a deep understanding of regulatory requirements, excellent communication skills, and a meticulous attention to detail, playing a key part in bringing life-changing medications to patients. If you are passionate about regulatory compliance and its impact on public health, we encourage you to apply.
Key Responsibilities:
Qualifications:
Our client offers a competitive salary, comprehensive benefits package including health, dental, and vision insurance, 401(k) with company match, generous paid time off, and significant opportunities for professional growth within a highly impactful industry. Join a team dedicated to ensuring safe and effective medicines reach patients globally.
Key Responsibilities:
- Prepare, compile, and submit regulatory documents, including INDs, NDAs, ANDAs, BLAs, and post-approval variations, to health authorities (e.g., FDA, EMA) in various electronic formats (e.g., eCTD).
- Interpret and apply complex regulatory guidelines and requirements to product development and lifecycle management.
- Act as a liaison between the company and regulatory agencies, responding to queries and managing submissions effectively.
- Provide regulatory input and guidance to cross-functional teams, including R&D, clinical, quality assurance, and manufacturing, throughout the product development process.
- Review and approve labeling, promotional materials, and other product-related communications for regulatory compliance.
- Maintain current knowledge of global regulatory intelligence, health authority guidance documents, and industry trends that impact pharmaceutical development.
- Participate in regulatory strategy meetings for new product development and lifecycle management.
- Manage and organize regulatory files, ensuring all documentation is accurate, complete, and readily accessible for audits.
- Identify potential regulatory risks and develop mitigation strategies.
- Assist in the preparation for and participate in regulatory inspections and audits.
- Ensure compliance with Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and Good Clinical Practice (GCP) requirements as they relate to regulatory submissions.
- Contribute to the development and improvement of internal regulatory processes and standard operating procedures (SOPs).
Qualifications:
- Bachelor's degree in Pharmacy, Life Sciences, Chemistry, or a related scientific discipline. Advanced degree (Master's or Ph.D.) is a plus.
- Minimum of 3-5 years of experience in regulatory affairs within the pharmaceutical or biotechnology industry.
- In-depth knowledge of FDA regulations (21 CFR), ICH guidelines, and global regulatory requirements (e.g., EMA, Health Canada).
- Proven experience with electronic submission systems, particularly eCTD.
- Excellent written and verbal communication skills, with the ability to articulate complex regulatory concepts clearly.
- Strong analytical and problem-solving abilities, with meticulous attention to detail.
- Ability to manage multiple projects simultaneously and work effectively under pressure to meet tight deadlines.
- Proficiency in Microsoft Office Suite and regulatory information management systems.
- RAC (Regulatory Affairs Certification) is highly desirable.
- Ability to work independently and collaboratively in a fast-paced, matrixed environment.
- Demonstrated ability to interpret scientific data and translate it into regulatory strategy.
Our client offers a competitive salary, comprehensive benefits package including health, dental, and vision insurance, 401(k) with company match, generous paid time off, and significant opportunities for professional growth within a highly impactful industry. Join a team dedicated to ensuring safe and effective medicines reach patients globally.
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1
Regulatory Affairs Specialist (Pharmaceutical)
20004 Washington, District Of Columbia
$95000 Annually
WhatJobs
Posted 15 days ago
Job Viewed
Job Description
Our client, a prominent pharmaceutical company dedicated to developing life-saving medications, is seeking a meticulous and experienced Regulatory Affairs Specialist to join their team in Washington, D.C., US . This pivotal role is responsible for ensuring that all pharmaceutical products and development processes comply with the rigorous requirements of regulatory agencies, particularly the FDA. The ideal candidate will have a strong background in pharmaceutical regulatory affairs, a deep understanding of submission processes, and a commitment to maintaining the highest standards of compliance. You will play a crucial role in bringing new and essential medicines to patients.
Responsibilities:
Qualifications:
If you are a highly organized and detail-oriented regulatory professional committed to ensuring the safety and efficacy of pharmaceutical products, our client offers a vital role in their mission to improve global health.
Responsibilities:
- Prepare, compile, and submit regulatory applications and dossiers (e.g., INDs, NDAs, ANDAs, BLAs, Supplements) to the FDA and other relevant regulatory authorities.
- Interpret and apply regulatory guidelines (e.g., FDA regulations, ICH guidelines) to drug development and manufacturing processes.
- Serve as a primary liaison with regulatory agencies, responding to inquiries and managing communication throughout the submission review process.
- Provide regulatory guidance and support to cross-functional teams, including R&D, clinical development, manufacturing, and quality assurance.
- Review and approve regulatory-related documents, such as clinical study reports, manufacturing batch records, and labeling, for compliance.
- Stay current with evolving regulatory requirements, industry trends, and scientific advancements, assessing their impact on company products and strategies.
- Develop and maintain regulatory intelligence databases and tracking systems.
- Participate in internal and external audits, ensuring regulatory preparedness.
- Manage regulatory aspects of post-market activities, including adverse event reporting and product changes.
- Identify potential regulatory risks and develop mitigation strategies.
- Assist in the development of regulatory strategies for new product candidates.
- Ensure all regulatory submissions are accurate, complete, and submitted in a timely manner.
Qualifications:
- Bachelor's degree in a scientific discipline (e.g., Pharmacy, Chemistry, Biology, Pharmacology) or related field. Master's degree or Pharm.D. preferred.
- Minimum of 4-6 years of experience in regulatory affairs within the pharmaceutical or biotechnology industry.
- In-depth knowledge of FDA regulations (e.g., 21 CFR), ICH guidelines, and GxP (GCP, GLP, GMP).
- Proven experience in preparing and managing various types of regulatory submissions (e.g., INDs, NDAs).
- Excellent understanding of the drug development lifecycle.
- Strong analytical, problem-solving, and critical thinking skills.
- Exceptional written and verbal communication skills, with a meticulous attention to detail.
- Ability to work independently and collaboratively in a fast-paced, highly regulated environment.
- Proficiency with electronic submission systems and regulatory databases.
- RAC (Regulatory Affairs Certification) is a strong plus.
- Demonstrated ability to manage multiple projects and deadlines.
If you are a highly organized and detail-oriented regulatory professional committed to ensuring the safety and efficacy of pharmaceutical products, our client offers a vital role in their mission to improve global health.
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