Director, Regulatory CMC - Biologics & Global Submissions
Neurocrine Biosciences
Neurocrine Biosciences in San Diego, California is seeking a Regulatory Affairs professional to lead CMC regulatory strategy and ensure compliance for biologics. With a strong focus on collaboration and communication, the role entails managing regulatory submissions to enable early approvals. The ideal candidate will possess a minimum of 12 years of experience in the pharmaceutical/biotech industry and comprehensive knowledge of FDA and EMA regulations. Competitive compensation and benefits package, including salary range of $187,900.00 – $256,000.00 and annual bonus opportunities, is offered. #J-18808-Ljbffr
$185k - $200k
...Associate Director Of Regulatory Affairs, Cmc The associate director of regulatory affairs,... ...independent author of cmc regulatory submissions and a key contributor to global health authority interactions.... ...and guidelines applicable to biologics and cell/gene therapy,...SuggestedRemote workFlexible hours$228k - $245k
...The Director, Global Regulatory Affairs will play a critical role in developing and... .... Lead the preparation, submission, and maintenance of... ...Therapeutic Discovery, and CMC teams. Monitor and interpret... ...knowledge of the development of biologics targeted for the treatment...SuggestedFull timeSummer workWork at officeRemote workRelocation packageMonday to Friday- ...Regulatory Cmc Leadership Role Responsible for the strategic regulatory... ...of IND/CTA/MAA/NDA/BLA submissions in a timely and efficient manner... ...strategic guidance on global regulatory CMC requirements... ...aspects for small molecules, biologics, and/or gene therapies. Leadership...SuggestedContract work
- ...healthcare innovation company in San Diego is looking for a Regulatory Affairs Director to lead global regulatory strategies. This role requires extensive experience in the IVD industry, with a focus on FDA submissions. The ideal candidate will work cross-functionally to...Suggested
$180k - $210k
...POSITION TITLE: Director of Regulatory Affairs POSITION SUMMARY... ...develop and execute global regulatory strategy,... ...responsible for regulatory submissions (including INDs),... ..., peptide, and/or biologics) across a broad range... ...Clinical development CMC/manufacturing...SuggestedFlexible hours- CorDx in San Diego, California is seeking an Associate Regulatory Affairs Manager to support regulatory document submissions for medical devices and IVD products. The ideal candidate will have a master's degree and 4-6 years of relevant experience, including 510(k) submissions...
- ...Fate Therapeutics, Inc. is seeking a Director, Regulatory Affairs to manage global clinical regulatory activities in innovative biotechnology programs. This role includes overseeing IND submissions, ensuring FDA compliance, and collaborating with cross-functional teams...Full time
- ...Associate Director Regulatory Affairs - Hybrid - San Diego We are partnering... ...in developing and executing global regulatory strategy across... ..., Clinical Operations, CMC, Nonclinical, Biometrics, Medical... ...planning Ensure submissions comply with applicable FDA and...Odd job
$190k - $260k
...products. Position Summary The Director, CMC - Formulations will... ..., clinical pharmacology and regulatory teams, the Director, CMC - Formulations... ...required Experience with biologics formulations preferred... ...from project start‑up through submission Excellent knowledge of Food...Contract workWork experience placementLocal area- ...Executive Director, Regulatory Strategy – Endocrinology The Executive Director, Regulatory Strategy... ...responsible for shaping and driving global regulatory strategy across Company's Endocrinology... ...Development, Safety, Commercial, CMC, Quality, and Legal to ensure aligned...
$154k - $193k
...Position Summary The Associate Director, Regulatory Affairs Project Planning & Coordination... ...best practices that facilitate how the Global Regulatory Affairs department executes... ...be involved in planning of regulatory submission timelines, compliance and maintenance...Work at officeLocal areaRemote workNight shift3 days per week$220k - $245k
...Fate Therapeutic is seeking a strategic and experienced Director, Regulatory Affairs to lead global clinical regulatory activities supporting innovative... ...strategy, and drive successful regulatory submissions and approvals. The ideal candidate will have extensive...Full time- The Director of Regulatory Affairs will be based in San Diego, CA The role includes but is not limited... ...regulatory strategies for new product submissions, handling existing product... ...variations and renewals, interacting with global internal stakeholders as well as external...Work experience placementWork at office
- ...Head of Global Regulatory Advertising and Promotion About the Company Industry shaping biopharmaceutical company Industry Biotechnology Type Public Company About the Role The Company is seeking a Head of Global Regulatory Advertising and Promotion...
$240k - $265k
...focusing on oral small molecule therapies. The Senior Director of Regulatory Affairs leads global regulatory activities and manages personnel for IND/... ...iPSP/PIP, NDA/MAA). Provide oversight of regulatory submissions vendors to assure technical accuracy, compliance, completeness...Work at officeRemote workFlexible hours- ...Contineum Therapeutics is seeking a Senior Director of Regulatory Affairs in San Diego, CA. This role leads regulatory activities for IND/CTA preparations and requires significant experience in the pharmaceutical/biotech industry. Candidates should have a Bachelor's degree...Remote work
- ...Executive Director of Global Pharmacovigilance About the Company Forward-thinking biotechnology company Industry... ...adverse events and safety data, and ensuring the timely submission of safety reports to regulatory authorities. This role requires a strategic leader...
$204.2k - $306.2k
...A leading technology firm is seeking a Senior Director of Export and Import Compliance in San Diego, California. This role focuses on leading the global trade compliance strategy and operations. The ideal candidate will have extensive experience in export compliance,...- ...We are searching for seasoned regulatory affairs consultants to integrate with... ...service organization with global clients investigating drugs, biologics, devices or combination products... ...clinical documents for regulatory submissions Act as regulatory lead or participate...Work at officeHome officeNight shift
- ...RegDev, Inc. is seeking experienced regulatory affairs consultants to support clients in developing and implementing regulatory strategies... ...years of relevant experience, including managing regulatory submissions and a solid understanding of US and international regulations...
- ...the US and around the world. Regulatory Affairs Consultant, In... ...in support of all regulatory submissions. Serve as the primary company... ...agencies sponsoring drugs and biologics is highly desirable. Combination... ...to the FDA and other global agencies, leveraging data from...Local areaRemote work10 hours per week
$105.8k - $132.25k
...Regulatory Affairs Specialist 3 - Medical Device IVD Location: CA-... ...millions of people? Grifols is a global healthcare company that... ...experience in the IVD or Drug/Biologics industry is required.... ...and post‑market regulatory submissions with the US FDA, Notified Bodies...Full timeContract workWork at officeLocal area$230k - $250k
...Director, Biology About Alterome Redefining precision oncology, one alteration at a time. Alterome is a clinical... ...leadership for IND enabling packages, regulatory interactions, and scientific contributions to submissions (e.g., Investigator Brochures, pharmacology sections...Work at officeHome officeFlexible hours3 days per week$220.6k - $275.7k
...office three days per week on average. Position Summary The Senior Director, Regulatory Operations provides strategic and operational leadership for global regulatory operations, overseeing electronic submissions, regulatory information management systems, and end‑to‑end...Work at officeLocal areaRemote workWorldwideNight shift3 days per week- ...A leading technology firm in San Diego is seeking a Senior Director of Export and Import Compliance to lead the global trade compliance strategy and operations. The successful candidate will have over 13 years of experience, including at least 5 years in a senior leadership...
$204k
...Associate Director, Outsourcing & Vendor Governance & Supplier Management (CMC) page is loaded## Associate Director, Outsourcing... ...with applicable GMP, GxP, and regulatory requirements.* Partner closely... ...Laboratory Activities (if applicable): Biology and chemical laboratory...Contract workLocal areaRemote work$107.16k - $226.32k
...investment in our people, our future, and what we stand for as a firm. KPMG is currently seeking a Manager / Senior Manager to join our Global Compliance Management Services practice. Responsibilities: Manage assigned global compliance engagements Lead client...Local areaRemote work- ...highly motivated and experienced Associate Director or Director to lead oncology drug... ...candidates from hit identification to IND submission. This role will set scientific direction... ...generation, and decision‑making across biology workflows. This is a high‑impact role that...Flexible hours
- ...Senior Executive Director, Regulatory Affairs About the Company Well-funded clinical-stage biotech company Industry Biotechnology... ...and tactical support in regulatory activities. This includes global regulatory strategy, managing health authority interactions,...
- Position Summary The Associate Regulatory Affairs Manager will support the development, review, and submission of regulatory documents for medical device and IVD products... ...ensuring compliance with FDA, ISO 13485, and other global regulatory requirements. The Associate...Work at officeFlexible hours
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