Regulatory Affairs Manager
3 weeks ago
ABOUT:
Are you passionate about advancing treatments for life-changing conditions? This global specialty pharmaceutical leader is transforming the landscape of genetic, metabolic, and systemic disorders. With a cutting-edge focus on melanocortin technology, they are on a mission to build a world-class melanocortin house-bringing hope to patients with life-threatening and acute conditions. With 10 products in the pipeline, ranging from pre-clinical to commercial, the company is looking to bring on a Regulatory Manager to their US site (California; However, this role can be remote)*.
Key Responsibilities:
- Assist in the development of the ongoing global regulatory strategy
- Submissions of NDAs and amendments
- Applications and submissions to the FDA as required following post approval obligations and commitments, as well as prepare response to questions raised by FDA
- Maintain all approvals by submitting annual updates as needed (example Orphan designations, Investigator Brochure)
- Support Quality and Pharmacovigilance colleagues in systems management
- Prepare and/or collate all documentation to support clinical trial applications
- Assist sites in submitting applications to IRBs, and preparing responses to questions raised by IRBs and updated documentation as required
- Ensure investigation medicinal product is supplied to the study sites in compliance with all regulatory requirements, including packaging
- Manage packaging material manufacturing and create secondary packaging material
- Review and approve contract manufacturer's specifications and packaging documents
Qualifications:
- Minimum 5 years pharmaceutical industry experience
- Proven experience in preparation of New Drug Applications
- Proven experience in regulatory management of centrally approved products
- Understanding of Orphan Drug requirements
- Proven understanding of eCTD Modules 1-5
- Preparation of marketing authorization applications in eCTD format
- Proven experience in labelling, pricing and reimbursement procedures (desirable)
- Preparation of CTAs to support clinical trials (desirable)
-
Regulatory Affairs Manager
1 month ago
San Francisco, United States SciPro Full timeRegulatory Affairs ManagerHybrid - 3 days onsite6 month initial contract (likely exetnsion and convert to FTE)Responsibilities:Manage planning, preparation, coordination, and submission of regulatory documents to global National Health Authorities. Such submissions may include Clinical, Preclinical, or CMC content. Correspond and collaborate with RevMed...
-
Regulatory Affairs Manager
3 weeks ago
San Francisco Bay Area, United States Meet Full timeDescriptionThe Senior Manager in Regulatory Affairs is responsible for developing and managing regulatory strategies to ensure compliance with U.S. FDA and global regulatory bodies. This role involves providing direct support for regulatory submissions in the U.S., APAC, and other regions. The Senior Manager will collaborate closely with clinical...
-
Director, Global Regulatory Affairs
5 days ago
San Francisco County, United States EPM Scientific Full time**Director, Global Regulatory Affairs - West Coast**A high-level position is now open for an exceptional Director of Global Regulatory Affairs based on the West Coast. This role offers the opportunity to spearhead regulatory strategies, navigate product development complexities and ensure compliance across international markets.As the guiding force behind...
-
Director, Global Regulatory Affairs
3 weeks ago
San Francisco County, United States EPM Scientific Full time**Director, Global Regulatory Affairs - West Coast**A high-level position is now open for an exceptional Director of Global Regulatory Affairs based on the West Coast. This role offers the opportunity to spearhead regulatory strategies, navigate product development complexities and ensure compliance across international markets.As the guiding force behind...
-
Director of Regulatory Affairs
1 month ago
San Francisco, United States SciPro Full timeAssociate Director / Director Regulatory AffairsHybrid - 3 days onsite6 month initial contract (likely exetnsion and convert to FTE)Responsibilities:Develop, implement, and maintain initiatives, processes, and procedures with a recognition of when to consult departmental senior concerning risks.Plan, prepare, and coordinate regulatory submissions, ensuring...
-
Regulatory Affairs Director
3 weeks ago
San Francisco, California, United States 10 Fitness Full timeAbout the RoleWe are seeking a highly skilled Regulatory Affairs Director to join our team at 10 Fitness. As a key member of our management team, you will be responsible for ensuring compliance with all relevant laws and regulations in the fitness industry.ResponsibilitiesDevelop and implement effective regulatory strategies to ensure compliance with...
-
Regulatory Affairs Attorney
1 week ago
San Francisco, California, United States Thomas Talent Network Full timeJob Title: Regulatory Affairs AttorneyAbout the RoleWe are seeking a highly skilled Regulatory Affairs Attorney to join our team at Thomas Talent Network. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with relevant laws and regulations.Responsibilities:Developing and implementing regulatory compliance...
-
Regulatory Affairs Manager
1 week ago
San Diego, California, United States CorDx Full time**About the Role:**The Regulatory Affairs Manager will play a crucial role in ensuring compliance with regulatory requirements and guiding the development of new medical devices at CorDx. This position requires strong leadership skills, excellent communication abilities, and a deep understanding of FDA regulations and ISO standards.**Key...
-
Regulatory Affairs Strategic Manager
7 days ago
South San Francisco, California, United States Remegen Biosciences, Inc. Full timeJob DescriptionWe are seeking a highly experienced Global Regulatory Affairs Director to join our team at RemeGen Biosciences, Inc.This role will be responsible for providing regulatory guidance to cross-functional project teams, ensuring compliance with international regulations, assessing regulatory risks, and engaging with health authorities.The...
-
Quality and Regulatory Affairs Director
3 weeks ago
San Francisco, California, United States Michael Page Full timeAbout the RoleWe are seeking an experienced Quality and Regulatory Affairs Director to join our client, a leading beverage manufacturing company. This is an exciting opportunity for a professional with a strong background in quality assurance and regulatory compliance.Key ResponsibilitiesLead the quality assurance and regulatory affairs team to ensure...
-
Senior Regulatory Affairs Associate
1 month ago
San Francisco, United States SciPro Full timeSenior Associate, Regulatory AffairsHybrid - 3 days onsite 6 month initial contract (likely exetnsion and convert to FTE)Responsibilities: Represent Regulatory Affairs on project teams and closely collaborate with multidisciplinary teams to identify submission requirements, coordinate the content and development process (planning, creation, review, and...
-
Regulatory Affairs Director
4 weeks ago
San Francisco, CA, United States Biolink360 Full timeCompany Location: Bay AreaComp: 150K-220KPosition Reports to: VP of Regulatory and Quality Director of Regulatory Affairs - San Francisco We are seeking a highly motivated and experienced Senior Director of Regulatory Affairs for a Medical Device Orthopedic Portfolio. This person will lead interactions with regulatory agencies globally and help develop...
-
Regulatory Affairs Associate
3 weeks ago
San Francisco Bay Area, United States Planet Pharma Full timePharmaceutical or Biotech Submission Experience Only (NO MEDICAL DEVICE)Responsibilities:Act as the point person from Regulatory Affairs in meetings, closely collaborating with cross-functional teams to identify submission requirements, and accurately coordinate content. Arrange regulatory submissions that meet ICH or FDA requirements.Oversee detailed...
-
san francisco county, United States EPM Scientific Full time**Director, Global Regulatory Affairs - West Coast**A high-level position is now open for an exceptional Director of Global Regulatory Affairs based on the West Coast. This role offers the opportunity to spearhead regulatory strategies, navigate product development complexities and ensure compliance across international markets.As the guiding force behind...
-
san francisco county, United States EPM Scientific Full time**Director, Global Regulatory Affairs - West Coast**A high-level position is now open for an exceptional Director of Global Regulatory Affairs based on the West Coast. This role offers the opportunity to spearhead regulatory strategies, navigate product development complexities and ensure compliance across international markets.As the guiding force behind...
-
Regulatory Affairs Specialist
3 days ago
Bucks County, United States On Site Personnel Full timeThe Regulatory Affairs Associate is responsible for regulatory submissions and maintaining submission information in a proper Regulatory Affairs systems. The incumbent work cross-functional with internal departments and external resources on source documents and Regulatory related issues, ensuring those are in compliance with FDA regulations and company...
-
Regulatory Affairs Specialist
6 days ago
Bucks County, United States On Site Personnel Full timeThe Regulatory Affairs Associate is responsible for regulatory submissions and maintaining submission information in a proper Regulatory Affairs systems. The incumbent work cross-functional with internal departments and external resources on source documents and Regulatory related issues, ensuring those are in compliance with FDA regulations and company...
-
Regulatory Affairs Associate
1 month ago
South San Francisco, United States BioSpace, Inc. Full timeJob Details Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients. We are seeking an exceptionally...
-
Director of Regulatory Affairs and Strategy
1 week ago
San Francisco, California, United States Daiichi Sankyo, Inc. Full timeJob DescriptionWe are seeking a highly skilled Director of Regulatory Affairs and Strategy to join our team at Daiichi Sankyo, Inc.About the RoleThis is a leadership position responsible for providing strategic and tactical regulatory guidance across our alliance products. The successful candidate will be accountable for developing and implementing effective...
-
Regulatory Affairs Associate
2 months ago
South San Francisco, United States Alumis Full timeJob DescriptionJob DescriptionAlumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients. We are seeking an...