The Chemistry Manufacturing Controls (CMC) Consultant / Senior Consultant will support the execution of global regulatory CMC strategies for cell and gene therapy products in development and on the market. This role involves preparing and submitting regulatory CMC documentation and providing guidance to cross-functional teams to ensure compliance with global regulatory requirements.
Responsibilities
- Support the execution of cell and gene therapy global regulatory CMC strategies for marketed and development products
- Contribute to the preparation and submission of regulatory CMC documentation
- Provide regulatory support and guidance to various cross-functional teams
- Ensure all applicable global regulatory requirements are considered and appropriately incorporated into development and commercial programs
Requirements
- Experience in Chemistry Manufacturing Controls (CMC) within the biopharmaceutical industry
- Experience supporting regulatory CMC strategies for cell and gene therapy products
- Ability to prepare and submit regulatory CMC documentation
- Proven ability to provide regulatory guidance to cross-functional teams
- Understanding of global regulatory requirements for CMC in cell and gene therapy
Preferred Qualifications
- Experience in a fully integrated biopharmaceutical solutions organization
- Experience working with FDA and EMA regulatory submissions
- Background in clinical development, medical affairs, or commercial insights related to cell and gene therapy
Technical Stack
Regulatory CMC documentation systems, Global regulatory submission platforms, Cell and gene therapy development frameworks
Benefits
- Career development and progression opportunities
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition programs
- Total rewards program
- Commitment to Total Self culture – authenticity and inclusion
- Exposure to emerging technologies, data, science, and knowledge sharing
- Comprehensive resources for professional growth
- Diversity and inclusion initiatives
- Opportunities for career advancement beyond initial role
Compensation
Not specified. Equity: Not specified. Total rewards program including recognition and career development
Work Arrangement
Hybrid — Serbia, Spain, UK, Portugal — Hybrid work model allowing flexibility between remote and office locations
The Company is committed to compliance with the Americans with Disabilities Act and the implementation of the EU Equality Directive in relation to recruitment and employment. It provides reasonable accommodations when appropriate.
