Regulatory Affairs CMC Specialist
6 days ago
Job Summary
We are seeking a highly skilled Regulatory Affairs CMC Associate to join our team at Fladger Assoc. Inc. in Foster City, CA. This is an exciting opportunity for a professional with a strong background in regulatory affairs and experience in supporting biologic and small molecule drugs.
About the Role
The successful candidate will provide regulatory support for investigational and commercial biologics and small molecule products, preparing and submitting documents to regulatory authorities in line with ICH requirements, regional regulations, and company policies.
Main Responsibilities
- Prepare and submit regulatory documents, including INDs, NDAs, BLAs, amendments, supplements, annual reports, and license renewals;
- Collaborate with cross-functional teams to ensure accurate and timely communication of critical information;
- Maintain knowledge of regulatory requirements and communicate changes to senior management and project teams;
- Provide input to senior regulatory professionals on country-specific labeling and product packaging updates;
- Support cGMP activities as they relate to regulatory affairs;
- Work under supervision of senior regulatory professionals and line manager in a matrixed organization;
Requirements
- BS/BA degree in a scientific field or equivalent experience;
- 2+ years of relevant pharmaceutical/biotech industry experience, preferably in regulatory affairs;
- Excellent organizational skills and ability to work on multiple projects with tight timelines;
- Strong verbal and written communication skills, as well as interpersonal skills;
- Ability to work well under demanding deadlines and maintain attention to detail;
- Understanding of regulatory requirements, including ICH guidelines and US regional regulations;
Compensation Package
The estimated salary for this position is $110,000 - $140,000 per year, depending on experience, with additional benefits such as medical insurance, 401(k) plan, and paid time off.
Location
This position is located in Foster City, CA, and we require candidates to be based in the Bay Area.
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