1,568 Regulatory Affairs Manager jobs in the United States

Join to apply for the Regulatory Affairs Manager role at Thermo Fisher Scientific

3 days ago Be among the first 25 applicants

Join to apply for the Regulatory Affairs Manager role at Thermo Fisher Scientific

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

As part of the Thermo Fisher Scientific team, youll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the worlds toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

The Regulatory Affairs Manager will draft and file documentation and submission materials fr new and/or existing products to regulatory authorities in support of global product registrations.

Key Responsibilities:

• Regulatory Strategy Development: Develop and implement regulatory strategies to achieve timely product approvals.
• Submission Preparation: Prepare and submit regulatory documents to relevant regulatory agencies (e.g., US, EU, Health Canada). Serve as primary point of contact with regulatory body, managing communications and addressing questions or concerns relative to product/project.
• Regulatory Intelligence: Monitor and interpret changes in regulatory guidelines and standards, and assess their impact on the company. Lead Regulatory communications to the broader organization on pertinent regulations updates.
• Compliance Monitoring: Ensure ongoing compliance with regulatory requirements, including post-market surveillance.
• Cross-functional Collaboration: Collaborate with R&D, PPM (product and project manager), QA, marketing, commercial and other departments to integrate regulatory requirements into product development and commercialization.
• Training: Administer training and mentorship to employees for understanding regulatory requirements and standard methodologies.
  
  

• Bachelors degree and/or Masters in Biology, Chemistry, bio-engineering or related scientific area.
  
  

• 5 years of medical device, IVD Regulatory Affairs experience to include either 510(k) or PMA, Notified Body (NB) submissions.
• Preference would be a former regulatory agency reviewer or staff (e.g FDA submission reviewer)
• Proficient in the aspects of regulatory strategy creation, design control, cGMP/Quality Systems, and import/export requirements.
• Experience in direct communication with regulatory agencies.
  
  

• Regulatory review experience of promotional marketing materials, press releases, labeling, etc.
• Strong oral and written communication skills, as well as the ability to provide scientific presentations!
• Ability to compile data and summarize results.
• Continuous improvement minded, familiar with balancing Quality and the need for efficiency!
  
  

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs
• Employee assistance and family support programs, including commuter benefits and tuition reimbursement
• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
• Employees Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
  
  

• Seniority level Not Applicable

• Employment type Full-time

• Job function Quality Assurance, Product Management, and Engineering
• Industries Pharmaceutical Manufacturing and Biotechnology Research

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• Monitor and analyze state and federal legislation, including California Senate and Assembly bills, that impact Medi-Cal, D-SNP, and delegated healthcare operations.
• Monitor and analyze regulatory updates and guidance from Medi-Cal (DHCS), CMS, and NCQA to assess organizational impact and ensure timely implementation.
• Utilize a combination of compliance tools and/or software solutions to support the tracking, analysis, and dissemination of regulatory and legislative changes; may include developing or customizing tools to meet organizational needs.
• Interpret regulatory updates and assess organizational impact.
• Serve as a liaison with regulatory agencies (e.g., DHCS, DMHC, CMS).
• Lead enterprise-wide implementation of new or revised regulatory and contractual requirements.
• Coordinate with internal stakeholders to ensure timely and effective compliance.

• Oversee the development, review, and maintenance of enterprise policies and procedures.
• Ensure alignment with current regulatory and contractual obligations.
• Maintain and manage a centralized policy repository using a policy management system integrated with internal platforms to ensure accessibility, version control, and audit readiness.

• Support internal and external audits, including pre-delegation, readiness, and FDR oversight.
• Coordinate corrective action plans and follow-up activities.
• Develop and implement auditing tools and templates to support internal and external compliance monitoring efforts.

• Support the Compliance / Privacy Officer in the identification, triage, and documentation of potential regulatory or privacy-related incidents, including HIPAA concerns.
• Assist in gathering preliminary information and coordinating with relevant departments to ensure timely escalation and resolution.
• Contribute to risk mitigation planning and ensure alignment with regulatory expectations and internal protocols.

• Develop and deliver training on regulatory requirements and compliance policies.
• Promote a culture of compliance and continuous improvement.

• Prepare and submit required reports to oversight agencies (e.g., DHCS, CMS) and contracted health plans, as applicable under delegated arrangements.
• Report to appropriate regulatory or law enforcement authorities when warranted by compliance investigations, HIPAA breaches, or other reportable incidents.

• Provide guidance and oversight to compliance staff, as needed.
• May supervise direct reports and support performance management, workload distribution, and professional development.

• Bachelor's degree in Healthcare Administration, Public Policy, Law, or a related field; OR an equivalent combination of education and progressively responsible experience in healthcare compliance or regulatory affairs.
• 3+ years of experience in healthcare compliance or regulatory affairs, preferably within a managed care organization, IPA, MSO, TPA, or other delegated entity.
• Strong understanding of California healthcare legislation, DHCS, DMHC, CMS, and NCQA requirements.
• Experience with regulatory monitoring, policy management, audit readiness, and delegation oversight.
• Prior experience managing or supervising staff, preferred.
• Excellent communication, analytical, and project management skills.

• Certification required: Certified in Healthcare Compliance (CHC) or Certified in Healthcare Privacy Compliance (CHPC), issued by the Compliance Certification Board (CCB); or ability to obtain certification within 24 months of hire.

Description

The Regulatory Manager will provide hands-on support for day-to-day regulatory functions. Responsibilities include the preparation, formatting, and editing of clinical components of documents for health authority submissions, maintaining the regulatory calendar of submissions, and, where applicable, managing interactions with Regulatory CROs as directed. This position can be based in our corporate HQ office- Coral Gables, Florida or remote, with one trip per quarter to HQ.

Requirements

Responsibilities (Included but not limited to):

• Prepare standard regulatory documents including INDs, NDAs, CTAs, Meeting Requests, Briefing Books, Orphan Drug Designations (ODDs), Annual Reports, DSURs, and PADERs.
• Author cover letters and prepare agency forms for submission
• Organize and track the internal review process of regulatory documents, including reconciliation of review comments, editing, formatting, version control, and finalization within the Veeva RIM Platform
• Compile and submit study-specific regulatory documents and safety filings to trial master files
• Submit and distribute regulatory documents to Catalysts partners and the Pharmacovigilance group
• Track recurring regulatory activities and manage submission timelines
• Maintain the departments regulatory submissions database
• Develop and manage regulatory project roadmaps; assist in developing regulatory plans
• Schedule regulatory project meetings and draft/distribute meeting minutes
• Provide administrative support and other duties as assigned
• Collaborate with cross-functional teams to define strategies for document authoring and preparation
• Collaborate with Regulatory Operations to enhance regulatory submission and information management capabilities within the Veeva RIM platform
• Support the implementation of the Veeva RIM platform in collaboration with internal and external stakeholders and vendors
• Assist in the development and maintenance of regulatory-specific Standard Operating Procedures (SOPs) and Work Instructions
• Use knowledge of GCP and study protocols to support regulatory compliance
• Monitor new and revised FDA recommendations and assist in preparing impact analyses
• Monitor regulatory intelligence related to the competitive landscape and assist in preparing impact assessments
• Support impact assessments related to new releases or updates made to the Veeva RIM platform

Education/Experience/Skills:

• Bachelors degree required (Science preferred; Non-Science and Legal backgrounds considered)
• Masters degree (MS/MA) in Regulatory Affairs or related fieldpreferred
• Minimum of 35 years of clinical regulatory experience
• Familiarity with clinical trial and drug development regulations
• Solid understanding of Good Clinical Practice (GCP) and end-to-end regulatory submissions and archival processes
• Experience compiling and submitting regulatory documents and safety filings
• Proficiency in Veeva Regulatory Information Management (RIM) platformrequired
• Strong computer skills, including MS Word, Excel, Outlook, and Adobe Acrobat
• Ability to quickly learn and adapt to new software and platforms
• Excellent written, verbal, and interpersonal communication skills
• Strong organizational, planning, and time management abilities with attention to detail
• Effective problem-solving and analytical skills
• Ability to work independently as a self-starter while maintaining a high degree of accuracy under tight deadlines
• Ability to understand complex regulatory discussions and synthesize cross-functional input across documents and projects.
• Able to coordinate cross-functional team meetings and interface professionally with internal and external stakeholders, both domestically and internationally
• Demonstrated ability to collaborate respectfully and communicate clearly within a team environment.
• Capable of identifying access or process issues and proposing appropriate resolution plans

Catalyst is committed to providing competitive wages and comprehensive benefits including health, dental, and vision insurance, generous paid time off, a retirement savings plan with Company Match, and more. Further details about our benefits package can be found here:

The base salary for this position will range from $115,000 to $138,000. Candidate experience, professional licensing, and geographic location will be taken into consideration.

EEO Statement

Catalyst Pharmaceuticals is an Equal Opportunity Employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status.

Recruitment & Staffing Agencies: Catalyst Pharmaceuticals does not accept unsolicited agency resumes. Agency resumes will only be accepted if the agency is formally engaged by Catalyst Human Resources.

Responsibilities: In this critical role, you will lead regulatory strategies, product submissions, and a team of talented regulatory affairs professionals to drive timely product approvals and ensure ongoing regulatory compliance in key markets such as USA (FDA), EU (MDR), China (NMPA), and more. You will work cross-functionally with Clinical, Global Regulatory Affairs counterparts, and other departments to ensure that all regulatory requirements are met efficiently and effectively.

Who are we:

Cosmetic Solutions is a leader in the development and manufacturing of scientifically proven, innovative personal care products. With a focus on, face, body, hair, OTC, and professional use formulations, we create some of the most cost effective, high quality and powerful products on the market.

Providing world class services to up and coming businesses, large established brands, physicians, estheticians and other skin care professionals; we specialize in research & development, custom formalization, graphic design, manufacturing, packaging and delivery.

Job Title: Regulatory Manager

Position Overview:

The Regulatory Manager in the Beauty & Personal Care Industry is a vital role responsible for ensuring compliance with regulatory requirements related to the development, manufacturing, and distribution of personal care products. This role involves staying current on industry regulations, guiding product development teams, and liaising with regulatory authorities, websites and reference sources to provide the necessary approvals so that CSIL and our clients can enter production confidently. The Regulatory Manager plays a crucial role in navigating the complex landscape of beauty & personal care and US OTC regulations to ensure the organization's products meet legal and safety standards

Organizational Relationships

Reports to:

• Vice President of R&D and Regulatory

Key Responsibilities

1. Regulatory and Compliance:
   • • Monitor and interpret local, national, and international regulations applicable to personal care and OTC product ingredient and labeling integrity.
     • Interpret and communicate regulatory requirements to internal stakeholders, clients and commercial resources in the GTM team.
     • Develop, implement, and maintain strategies to ensure ongoing compliance with regulatory requirements for formulations.
2. Strategy Development:
   • • Collaborate with cross-functional teams to develop regulatory strategies that align with business goals.
     • Provide proactive regulatory awareness vs. reactive correction
3. Product registration and Certification:
   • • Manage the preparation and submission of regulatory documents and product registrations to regulatory authorities.

1) NDC, Organic registration, WERCS, MoCra registration for CS brands

1. • • Liaise with regulatory agencies to obtain necessary approvals for new products and ensure timely renewals of existing ones.
     • Work with certification providers and clients for certification of NSF Organic, Vegan, Gluten-free, Reef-friendly, ecocert, etc.
     • Liaise with GTM team resources regarding prioritization of work and whether or not there is a charge for certification work.
2. Labeling and Claims Compliance:

• Ensure product labeling complies with regulatory requirements used in personal care and OTC products.
• Collaborate with suppliers to obtain necessary documentation and ensure ingredients and formula compliance.

1) PROP 65, non-nan, IFRA, Allergens, etc.

• Validate formula claims.

1) Clean at Sephora, Ulta, Vegan, Leaping Bunny

1. Quality Management:

• Work closely with Quality Assurance and Compliance teams to integrate regulatory requirements in quality management systems.
• Support in quality audits and inspections related to regulatory compliance

1. Risk Assessment and Mitigation:

• Conduct risk assessments for new product formulations at the beginning of the project. Review and validate PDRs with R&D.
• Provide guidance on mitigating regulatory risks associated with product development and manufacturing processes.

1) Master Formula Approval Packet review

• Liaison with external partners to provide necessary safety assessment documentation.

1. Documentation and Record Keeping:

• Create and maintain accurate and organized regulatory documentation, including product dossiers (PIF) and regulatory submissions.

1) QQF, QIL, manufacturing procedure, formula SDS, Certificate of Free Sale, Letter of Authorization/Letter of Limited License

• Ensure that records are audit ready and accessible for regulatory inspections.
• Authenticate regulatory documentation required for customer product registration

1. Communication and Training:

• Communicate regulatory updates to relevant departments.
• Develop and deliver training to educate cross functional teams on regulatory.

Equal Employment Opportunity

Cosmetic Solutions is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Responsibilities: Join a leading biopharma company supporting critical regulatory systems initiatives. We're seeking a detail-oriented consultant with expertise in regulatory systems, eCTD submission management, and experience working with global IT and cross-functional teams to drive system implementation and quality control process, documentation & testing. Key focus area.

Responsibilities: In this critical role, you will lead regulatory strategies, product submissions, and a team of talented regulatory affairs professionals to drive timely product approvals and ensure ongoing regulatory compliance in key markets such as USA (FDA), EU (MDR), China (NMPA), and more. You will work cross-functionally with Clinical, Global Regulatory Affairs counterparts, and other departments to ensure that all regulatory requirements are met efficiently and effectively.

Responsibilities: In this critical role, you will lead regulatory strategies, product submissions, and a team of talented regulatory affairs professionals to drive timely product approvals and ensure ongoing regulatory compliance in key markets such as USA (FDA), EU (MDR), China (NMPA), and more. You will work cross-functionally with Clinical, Global Regulatory Affairs counterparts, and.

Join to apply for the Regulatory Affairs Manager role at Katalyst CRO

3 days ago Be among the first 25 applicants

Join to apply for the Regulatory Affairs Manager role at Katalyst CRO

• In this critical role, you will lead regulatory strategies, product submissions, and a team of talented regulatory affairs professionals to drive timely product approvals and ensure ongoing regulatory compliance in key markets such as USA (FDA), EU (MDR), China (NMPA), and more.
• You will work cross-functionally with Clinical, Global Regulatory Affairs counterparts, and others to support innovation and expand market access for our advanced ultrasound technologies and solutions.
• Develop and implement global regulatory strategies for new product registrations, software updates (including AI-powered features) and product lifecycle management.
• Lead preparation and submission of technical documentation and regulatory dossiers to authorities such as NMPA, FDA, EU notified bodies, and other international regulatory agencies.
• Oversee and coach a team of regulatory professionals to support both strategic and operational objectives.
• Interpret and apply regulatory requirements for medical devices (including IEC/ISO standards, NMPA, FDA 510(k), MDR, etc.).
• Define and execute submission strategies to meet timelines and business goals.
• Act as liaison to regulatory authorities and internal/external stakeholders; manage interactions and responses during submission review.
• Monitor changes in international regulatory environments and communicate impacts to internal teams.
• Represent the company in industry groups or regulatory associations, where appropriate.
• Support training and knowledge-sharing on country-specific regulatory requirements within the organization.
  
  

• In this critical role, you will lead regulatory strategies, product submissions, and a team of talented regulatory affairs professionals to drive timely product approvals and ensure ongoing regulatory compliance in key markets such as USA (FDA), EU (MDR), China (NMPA), and more.
• You will work cross-functionally with Clinical, Global Regulatory Affairs counterparts, and others to support innovation and expand market access for our advanced ultrasound technologies and solutions.
• Develop and implement global regulatory strategies for new product registrations, software updates (including AI-powered features) and product lifecycle management.
• Lead preparation and submission of technical documentation and regulatory dossiers to authorities such as NMPA, FDA, EU notified bodies, and other international regulatory agencies.
• Oversee and coach a team of regulatory professionals to support both strategic and operational objectives.
• Interpret and apply regulatory requirements for medical devices (including IEC/ISO standards, NMPA, FDA 510(k), MDR, etc.).
• Define and execute submission strategies to meet timelines and business goals.
• Act as liaison to regulatory authorities and internal/external stakeholders; manage interactions and responses during submission review.
• Monitor changes in international regulatory environments and communicate impacts to internal teams.
• Represent the company in industry groups or regulatory associations, where appropriate.
• Support training and knowledge-sharing on country-specific regulatory requirements within the organization.
  
  

• BS/MS degree or equivalent experience required.
• Expertise with global medical device regulations and registration processes, especially USA 510(k) and EU MDR.
• Superior presentation skills when communicating with all levels of the organization, business partners, and external sources.
• Ability to work with evolving technologies, systems, and global teams in a fast-paced, matrixed environment.
• Department of Commerce through the Export Administration Regulations (EAR), by the Department of State through the International Traffic in Arms Regulations (ITAR), and by the Treasury Department through the Office of Foreign Assets Control (OFAC) sanctions regulations.

• Seniority level Associate

• Employment type Contract

• Job function Legal
• Industries Pharmaceutical Manufacturing

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