Position Details
About this role
This role involves leading regulatory CMC strategies for biologics, preparing submissions, and ensuring compliance with global guidelines. The candidate will mentor staff and collaborate across departments.
Key Responsibilities
- Implement regulatory strategies
- Prepare and submit CMC sections
- Collaborate on global assessments
- Mentor junior staff
- Ensure compliance with regulations
Technical Overview
Expertise in biologics regulatory CMC, IND/BLA submissions, global regulatory assessments, and post-approval changes. Knowledge of analytical development and quality assurance processes.
Ideal Candidate
The ideal candidate is a senior regulatory affairs professional with over 10 years of biologics CMC experience, familiar with global regulatory strategies, IND/BLA submissions, and post-approval changes, capable of mentoring junior staff and leading regulatory assessments.
Must-Have Skills
Nice-to-Have Skills
Tools & Platforms
Required Skills
Hard Skills
Soft Skills
Industry & Role
Keywords for Your Resume
Deal Breakers
Less than 10 years biologics CMC experience, Lack of experience with IND/BLA submissions, No global regulatory strategy experience, No mentoring or leadership experience
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