# Regulatory Affairs Manager, CMC mRNA Vx Development Products

**Company**: GSK
**Location**: Pennsylvania - Upper Providence
**Work arrangement**: hybrid
**Experience**: senior
**Job type**: full-time
**Salary**: $113,850 to $189,750
**Category**: Healthcare
**Industry**: Healthcare

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## Description

As a Regulatory Affairs Manager in Chemistry, Manufacturing, and Controls (CMC) for mRNA-based vaccine development products, you will lead key regulatory activities that guide products from late-stage development through early lifecycle management.

In close partnership and collaboration with cross-functional teams including regulatory, manufacturing, quality, and development, you will help shape regulatory CMC strategies that ensure compliance and timely approvals.

Responsibilities:

- Development and execution of CMC (Module 3/2.3) regulatory strategies for vaccine products, ensuring alignment with U.S. regulatory expectations and global requirements (mainly Europe and Japan), including health authority interactions

- Prepare, review, and check CMC documentation for regulatory submissions (IND/CTA, BLA/MAA/JNDA and early life cycle variations) and consultations to meet regulatory compliance and quality standards.

- Collaborate with and provide timely regulatory advice to cross-functional CMC workstreams and matrix teams including manufacturing and quality to support RA CMC strategy development and flawless execution

- Contribute to planning and tracking of CMC source documents and dossier sections to ensure Right-First-Time submission readiness.

- Identify regulatory risks and propose mitigation plans to ensure smooth project progress and successful submissions.

- Support team members, fostering continuous improvement and sharing best practices in CMC regulatory affairs.

Basic Qualifications & Skills:

- A minimum of a Bachelor’s degree in life sciences, pharmacy, chemistry, biotechnology, or a related scientific discipline.

- Minimum of 2 years of experience in CMC regulatory affairs, with exposure to vaccine or biologics development and regulatory submissions.

- Minimum of 1 year of experience preparing or contributing to CMC sections of regulatory submissions in the US and EU markets for biologicals and/or vaccines.

Preferred Qualifications & Skills:

- Advanced degree (Master’s or PhD) in a scientific or regulatory field.

- Knowledge of U.S. and global regulatory requirements including FDA regulations, Good Manufacturing Practices (GMP), and guideline standards (e.g. ICH) for biologicals/vaccines.

- Experience working collaboratively within cross-functional teams across regulatory, manufacturing, quality, and development functions.

- Good awareness of AI tools and eagerness to apply them responsibly to increase efficiency and/or quality of RA deliverables.

- Experience with the preparation of regulatory interactions and negotiations including FDA meetings (e.g. Type C or pre-BLA), CHMP Scientific advice and /or PMDA consultations.

- Proven ability to develop and implement CMC strategies for complex vaccine or biologics products while managing multiple priorities and deadlines in a dynamic environment.

- Familiarity with electronic submission formats and systems (e.g. Veeva)

- Experience supporting regulatory inspections and providing input on manufacturing or process changes.

Benefits:

- Competitive salary

- Annual bonus based on company performance

- Healthcare and wellbeing programs

- Pension plan membership

- Shares and savings programme

- Performance with Choice programme offering remote or hybrid working model

## Skills

### Required
- Communication
- Digital Fluency
- Influencing Without Authority
- Learning Agility
- Pharmaceutical Regulatory Compliance
- Problem Solving
- Regulatory Strategies
- Strategic Leadership

### Nice to have
- Advanced degree in scientific or regulatory field
- Knowledge of FDA regulations
- Experience with AI tools
- Familiarity with electronic submission formats

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