What are the responsibilities and job description for the Manager Global Regulatory Affairs position at SoTalent?
Job Title : Manager Global Regulatory Affairs
Location : Boston, Massachusetts, United States
Job Type : Full Time
As our client is looking for a skilled Regulatory Affairs CMC professional, this role offers an opportunity to support global Chemistry, Manufacturing & Controls (CMC) and device-related regulatory activities across the product lifecycle, from clinical development through commercialization.
Role Overview
The successful candidate will support and execute regulatory CMC strategies under guidance, contribute to high‑quality global submissions, and collaborate closely with cross‑functional development, manufacturing, and commercial teams to ensure regulatory compliance and successful product progression.
Key Responsibilities
- Support and lead (with appropriate supervision) regulatory CMC activities for investigational, registration, and post‑approval submissions
- Act as a regulatory CMC representative on cross‑functional project teams during development and commercialization
- Define CMC data and documentation requirements and review submission content for accuracy and compliance
- Apply global regulatory CMC requirements, guidelines, precedents, and regulatory intelligence effectively
- Contribute to preparation for Health Authority interactions on CMC-related topics
- Liaise with international Health Authorities on procedural and administrative matters when required
- Assess manufacturing and CMC change proposals for potential global regulatory impact
- Proactively communicate risks, challenges, and regulatory considerations to stakeholders and management
- Build strong, collaborative relationships with internal teams and external partners
- Support and enhance regulatory compliance across assigned projects
Qualifications & Experience
- Bachelor’s degree in a scientific discipline required; advanced degree preferred
- 6 years of experience in Regulatory Affairs CMC or related pharmaceutical functions
- Experience supporting IND/IMPDs, leading major variations/amendments, or contributing to NDA/BLA submissions preferred
- Relevant experience in pharmaceutical development, analytical development, manufacturing, or quality may also be considered
- Solid understanding of global regulatory CMC requirements across development and post‑approval stages
- Strong analytical skills with high attention to detail
- Ability to evaluate alternative regulatory approaches using both guidelines and regulatory precedents
- Proven ability to communicate regulatory strategy to cross‑functional teams
- Sound judgment in issue escalation and decision-making
- Excellent written and verbal communication skills
- Demonstrates collaboration, emerging leadership, adaptability, and commitment to inclusivity