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 Neurocrine Biosciences
$132.7k - $182k
Neurocrine Biosciences is seeking a CMC Regulatory Affairs Manager in San Diego, California. This role involves overseeing regulatory activities for development and marketed projects, managing submissions, and ensuring compliance with government regulations. The ideal...Suggested$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- ...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
$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- ...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
...Director of Regulatory Affairs Calibr-Skaggs Institute for Innovative... ...develop and execute global regulatory strategy,... ...for regulatory submissions (including INDs), regulatory... ..., peptide, and/or biologics) across a broad range... ...development CMC/manufacturing Quality...Flexible 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
- ...Associate Director CMC Company Description: Revelation... ..., manufacturing, and regulatory compliance of... ...documentation for regulatory submissions (IND, BLA/NDA) to ensure compliance with global health authorities.... ...requirements (FDA/EMA) for biologics or small molecules....Contract work
$180k - $210k
...nonprofit research institute in San Diego seeks a Director of Regulatory Affairs to guide regulatory strategies and management of submissions. Candidates should have over 12 years of... ...include leading interactions with global health authorities, overseeing compliance,...- The role is for a CMC Regulatory Affairs Manager, responsible for day‑to‑day internal regulatory activities across development and marketed... ...the US. Assist and provide guidance to other departments and submission authors. Produce high‑quality regulatory submissions...Contract work
$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- 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
$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- ...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...
- ...Executive Director of Global Pharmacovigilance About the Company Forward-thinking biotechnology company Industry... ...events and safety data, and ensuring the timely submission of safety reports to regulatory authorities. This role requires a strategic leader with...
$145k - $165k
...We are seeking a motivated Regulatory Affairs professional to join... ...regulatory operations, quality, CMC, nonclinical and clinical functions... ...-quality, timely regulatory submissions. The ideal candidate is a... .... Familiarity with global regulatory requirements and guidelines...Odd jobWork at office- ...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
$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,...Work at officeRemote workFlexible hours$228k - $245k
A biotechnology firm is seeking a Director of Global Regulatory Affairs in San Diego. This role involves developing and executing regulatory strategies to support clinical programs and interaction with global regulatory agencies. Candidates should have a BS in life sciences...- 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 job
$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, with...- ...partners closely with Commercial, Clinical, CMC, Quality, Regulatory, and Operations to ensure all company... ...-border transfers of technology, biological materials, data, and equipment.... ...Therapeutics does not accept candidate submissions or referrals from recruiting agencies...
- 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
- A leading global transport and logistics firm is seeking a Customs Specialist - Entry Writer in San Diego, CA. This role requires performing Customs business activities, managing transactions with U.S. Customs, and ensuring compliance with regulations. The ideal candidate...Full time
$105.8k - $132.25k
Regulatory Affairs Specialist 3 - Medical Device IVD Location: CA-San... ...of people? Grifols is a global healthcare company that since... ...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- .... This role involves managing export classifications and collaborating with several departments to ensure compliance with U.S. and global regulations. The ideal candidate will have a Bachelor's degree and at least 5 years of experience in export compliance, focusing on...
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