Associate Director, CMC Regulatory Affairs
$166.4k - $249.6kVertex Pharmaceuticals
Vertex Pharmaceuticals seeks an Associate Director in CMC Regulatory Affairs to lead global regulatory strategies for investigational and marketed products. The role involves preparing and filing regulatory submissions, managing health authority interactions, and providing CMC guidance across cross-functional teams in Boston.
Responsibilities
- Lead preparation, review, and submission of CMC regulatory sections and health authority interactions
- Develop and execute global CMC regulatory strategies for assigned products
- Provide CMC regulatory guidance to cross-functional teams and key stakeholders
- Manage regulatory assessments on compliance topics including changes, deviations, and investigations
- Supervise regulatory staff and serve as primary CMC contact for assigned products
Requirements
- Bachelor's degree in Biology, Chemistry, Pharmacy, Regulatory Affairs, or related life-science field
- 8+ years of pharmaceutical, biotech, or related industry experience
- Advanced knowledge of FDA, EMA, Health Canada, and ICH regulatory guidelines
- Excellent interpersonal and communication skills for complex concepts
- Strategic thinking and cross-functional problem-solving abilities
- Strong planning, prioritization, and stakeholder management skills
Compensation: $166,400–$249,600 base; eligible for annual bonus and equity awards
Vacancy posted 6 days ago
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