Regulatory Affairs Specialist
3 days ago
Job Duration: 6 Months
Job Location: Foster City, CA
Responsibilities:
- Prepare Quality sections of INDs/IMPDs, new marketing authorization applications, post-approval variations, renewals, and responses to agency questions for biologics products.
- Interact with departments outside of CMC Regulatory Affairs to define strategy and submission plans.
- Ensure dossiers meet ICH and local regulatory requirements.
- Act as regional CMC Regulatory lead for assigned products and territories within a global matrix team.
- Liaise with Regulatory Affairs therapeutics teams, Client local Affiliates, Regulatory Operations, Regulatory Project Management, and third-party local agents to develop filing plans and deliver submissions.
- Coordinate regulatory assessments for post-approval CMC changes, develop filing strategy and plans for assigned markets, and execute filings.
- Maintain current awareness of CMC registration requirements in each International region and communicate key regulatory intelligence to the organization.
Requirements:
- BA/BS, MS, or Ph.D. or equivalent education.
- Significant experience in Regulatory Affairs CMC and/or relevant pharmaceutical industry experience.
- Experience in preparing CMC components of MAA or post-approval variation submissions for small molecule and/or biologics products.
- Biologics experience or drug-device combination product experience is an advantage.
- Proven ability to coordinate the preparation of CMC regulatory documents in collaboration with other functions.
- Proven strategic thinking skills with a track record for developing global CMC regulatory strategies in multiple markets simultaneously.
- In-depth knowledge of ICH and regional CMC regulatory requirements and understanding of current global and regional trends in CMC Regulatory Affairs.
- Experience representing CMC regulatory affairs on regulatory and cross-functional teams.
- Excellent written and verbal communication skills.
Preferred Skills:
- Experience with Veeva Vault, including RIM.
- Global regulatory expertise.
About this role:
This role is a great opportunity to gain experience in a CMC RA team, develop knowledge of Regulatory Affairs, and support the team in other regulatory-related activities while working in data entry.
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