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Key Responsibilities:
- Review CMC sections of regulatory submissions for development and commercial device programs.
- Contribute to global regulatory CMC strategies for drug-device combination products.
- Serve as primary regulatory CMC contact on cross-functional teams.
Qualifications:
- Bachelor's degree in a related life-science field with 4+ years of experience.
- Experience supporting regulatory submissions for combination products like autoinjectors and prefilled syringes.
- Knowledge of FDA, EU MDR, and ISO standards.
Required Skills:
- Strong interpersonal and communication skills.
- Proficiency in Design Controls, cGMP, and regulatory guidelines.
- Problem-solving and collaboration abilities.
Vertex Pharmaceuticals
Vertex Pharmaceuticals is a global biotechnology company dedicated to developing transformative medicines for serious diseases. With thousands of employees, it fosters a collaborative and innovative culture focused on patient impact.