- Lead a team of stakeholders to develop/implement effective CMC regulatory strategies for submissions (e.g. BLA/MAA) and identify regulatory risk
- Ensure oversight of multiple programs and drive regulatory CMC strategy successfully
- Lead and be responsible for module 3 of the regulatory submissions
- Provide strategic advice to manufacturing and quality teams on complex technical and regulatory CMC topics
- Evaluate proposed manufacturing and quality changes
- Review documents for submission-readiness, to ensure that all submissions conform to relevant guidelines
- Manage interactions and maintain excellent relationships with regulatory authorities
- Represent the company in front of FDA and EMA and or local regulatory authorities and be able to defend the companys strategy
- MS/PhD degree in a scientific/engineering discipline
- Experience representing the teams in front of FDA/EMA
- 10+ years of experience in regulatory CMC at global level, including biological medicinal products, including writing and compiling module 3
- Strong knowledge of current US, EU, and rest of the world regulations
- Strong experience with CTD format and content regulatory filings
- Demonstrated ability to deliver high quality regulatory CMC documents, and influence of regulatory authorities
- Exceptional written and oral communication
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Sr. Manager, Regulatory CMC
2 weeks ago
Neurocrine Biosciences San Diego, United StatesWho We Are: · At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve suffering ...
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Assoc. Regulatory CMC Director
3 weeks ago
Neurocrine Biosciences San Diego, United StatesWho We Are: · At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve suffering ...
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Assoc. Regulatory CMC Director
12 hours ago
Neurocrine Biosciences San Diego, United States Full timeWho We Are: · At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve suffering ...
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Sr. Dir/Director of Regulatory CMC
2 weeks ago
BioPhase San Diego, United StatesRemote - Candidates must be located in the United States - Ideally Southern California · The Sr. Director/Director of CMC Regulatory Affairs will be responsible for developing, leading and executing CMC regulatory strategies and activities for the organization, including the pre ...
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Director, Clinical Pharmacology
3 weeks ago
Equillium San Diego, United StatesThe Director of Clinical Pharmacology will lead the development and implementation of clinical pharmacology strategies for small molecules and biologics within the company's portfolio. They will offer expertise in analyzing pharmacokinetics, absorption, distribution, elimination ...
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Artiva Biotherapeutics San Diego, United States**About Artiva** · **Job Summary** · The Manager, GxP Validation, Calibration, and Engineering, is responsible for developing the Validation and Calibration functions at Artiva, which include managing consultants and contractors to support operation activities such as facility bu ...
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Executive Director/vice President, Clinical
3 days ago
VENTYX BIOSCIENCES, INC. San Diego, United StatesVentyx Biosciences, Inc. is a clinical-stage, public biopharmaceutical company focused on advancing new therapies for millions of people living with inflammatory diseases and autoimmune disorders. We are developing novel and differentiated therapeutics that target both the innate ...
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Supervisor, Customer Care
1 week ago
Magellan Health San Diego, United StatesPrimary function is to supervise the customer care staff responsible for responding to telephone inquiries from providers and members as they relate to eligibility, benefits, claims, and authorization of services. Supervises the staff in the implementation, servicing, and mainten ...
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Grievance & Appeals Analyst
1 week ago
Community Health Group Chula Vista, United States*** · Gathers information and resolves customer concerns presented as a grievance or appeal. Works closely with internal departments and providers' staff to obtain pertinent information in a timely manner and in compliance with regulatory requirements. Appropriately documents mem ...
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Clinical Dynamix, Inc. San Diego, United StatesAbout the Role: · Seeking a highly motivated and talented biologics leader within CMC (antibodies, gene therapy) in the areas of upstream and downstream API development, optimization and manufacture. The successful candidate will work on research and development of biologics proc ...
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Head, CMC
1 week ago
Z-Alpha Therapeutics San Diego, United StatesZ-Alpha Therapeutics is a pharmaceutical company dedicated to the discovery and development of radiotherapeutics targeting key biological pathways for solid tumors. The company has a revolutionary technology platform in the next generation of alpha particle therapy with potential ...
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Kumquat Biosciences San Diego, United States: · Location: San Diego, CA 92121 · Position type: Full time · Job Code: KB-CMC-XX · Required education: Ph.D. Degree (preferred) /Master's Degree · Area(s) of expertise desired: Analytical chemistry or related field · Description · Kumquat Biosciences is committed to the discove ...
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Viking Therapeutics San Diego, United Statesread more " · Purpose of Role: · This position reports to the Vice President of pharmaceutical development. The associate research associate/scientist will contribute to the ongoing efforts to develop first-in-class or best-in-class therapies for metabolic and endocrine disorders ...
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Senior Director
3 weeks ago
BioPhase San Diego, United StatesThe Senior Director overseeing Drug Product Development will lead the integration and supervision of all aspects of product development, encompassing pre-formulation sciences, formulation development, device development, and packaging development. A key responsibility will be the ...
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Kumquat Biosciences Inc San Diego, United StatesJob Description · Job DescriptionDescription:Kumquat Biosciences is committed to the discovery and development of innovative drugs to transform cancer treatments. Kumquat brings together an accomplished management team and distinguished scientific founders to translate innovative ...
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Shelby American Inc San Diego, United StatesLocation: · San Diego, CA 92121 · Position type: · Full time · Job Code: · KB-CMC-XX · Required education: · Ph.D. Degree (preferred) /Master's Degree · Area(s) of expertise desired: · Analytical chemistry or related field · Description · Kumquat Biosciences is committed to ...
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Kumquat Biosciences Inc San Diego, United StatesJob Description · Job Description Description: · Location: · San Diego, CA 92121 · Position type: · Full time · Job Code: · KB-CMC-XX · Required education: · Ph.D. Degree (preferred) /Master's Degree · Area(s) of expertise desired: · Analytical chemistry or related field · ...
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Vice President, Regulatory Affairs
2 weeks ago
Device Search Group San Diego, United StatesWe are seeking an experienced Senior Director or Vice President of Regulatory Affairs (DOE). · As the head of Regulatory Affairs you will be responsible for leading and managing all aspects of Clinical and CMC Regulatory Affairs. The ideal candidate will have a strong background ...
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ANAPTYSBIO San Diego, United StatesJob DescriptionJob Description AnaptysBio Inc · All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, gene ...
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Sr. Director Regulatory Affairs
2 weeks ago
EPM Scientific San Diego, United StatesSenior Director Regulatory Affairs · San Diego, California · Compensation: $200,000-307,000 + Bonus + Equity · Company Summary: · We are partnered with an Cell Therapy focused company looking to revolutionize the way we approach cell therapy within Oncology as well as other Thera ...
Sr. Dir/Director of Regulatory CMC - San Diego, United States - BioPhase
Description
Remote - Candidates must be located in the United States - Ideally Southern California
The Sr. Director/Director of CMC Regulatory Affairs will be responsible for developing, leading and executing CMC regulatory strategies and activities for the organization, including the preparation and filing of BLA submissions. This position is a hands-on role, providing both strategic and operational activities to support regulatory needs for rare disease studies. This role will report to the global Head of Regulatory.
Responsibilities:
Education and Experience:
