GSK
Regulatory Affairs Manager, CMC mRNA Vx Development Products
$114K–$190K
USA - Pennsylvania - Upper Providence +3 · Hybrid (Remote & On-site) · Manager · Full-time · Posted Oct 29, 2026
- Location
- USA - Pennsylvania - Upper Providence
USA - Massachusetts - Waltham
Rockville Tower Oaks Blvd
Durham Blackwell Street - Experience
- Minimum 2 years in CMC regulatory affairs and minimum 1 year preparing or contributing to CMC sections of submissions in US and EU markets.
- Education
- Bachelor’s degree in life sciences, pharmacy, chemistry, biotechnology, or a related scientific discipline.
About the job
Leads CMC regulatory strategy and submission activities for mRNA vaccine development products from late-stage development through early lifecycle management.
What you'll do
- Develop and execute CMC regulatory strategies, including health authority interactions, aligned with U.S. and global requirements.
- Prepare and review CMC documentation for regulatory submissions and consultations; coordinate dossier readiness across teams.
- Advise cross-functional teams, identify regulatory risks, and propose mitigation plans.
What they ask for
- Bachelor’s degree in life sciences, pharmacy, chemistry, biotechnology, or a related scientific discipline.
- At least 2 years of CMC regulatory affairs experience, with exposure to vaccine or biologics development and regulatory submissions.
- At least 1 year preparing or contributing to CMC submission sections for biologicals and/or vaccines in the US and EU markets.
Nice to have
- Advanced degree (Master’s or PhD) in a scientific or regulatory field.
- Knowledge of FDA, GMP, and ICH requirements; experience with regulatory interactions, Veeva, inspections, or responsible use of AI tools.
Pay
USD 113,850 to USD 189,750 annual base salary
Tools
IND, CTA, BLA, MAA, JNDA, FDA, GMP, Veeva
AI focus
Preferred awareness of AI tools and interest in applying them responsibly to improve efficiency and/or quality of regulatory affairs deliverables.
Model-written summary · the original posting is authoritative