The Associate Director position, Regulatory Affairs Global CMC will be responsible for managing and leading registration and CMC regulatory support for commercial and development projects worldwide.
Essential Job Functions:
- Planning and co-ordination of the writing and reviewing Module 2 and 3 CTD sections of all regulatory submissions (INDs, IMPDs, CTAs, MAAs, NDAs, BLAs, meeting requests, and briefing documents).
- Leads functional/department multi-disciplinary teams in complex, business critical projects to establish Regulatory CMC strategies for commercial products, late, and early stage development programs. Solves unique and complex problems that have a broad impact on the function and/or broader department.
- Provide in-depth reviews of protocols, reports, presentations, and documents, anticipating internal and/or external business challenges and/or regulatory issues
- Regularly interacts with functional leaders, and in some cases senior leadership and/or major customers, on matters concerning functional area, business unit or additional business areas., including regulatory agency interactions.
- Coordinate the preparation and timely submission of responses to regulatory agencies. Manage timelines to ensure approvals are timely and development objectives are met.
- Contributes to the development of functional and/or broader department strategy and to departmental plans, including planning, staffing, budgeting and/or prioritization
- Identify and lead continuous improvement opportunities for the GRA-CMC team and the broader GRA team.
- Monitor EU and US CMC regulations, and assess any changes to ensure all development activities are in compliance with applicable current regulations and guidelines.
- Ensure continued regulatory compliance of products though adherence to the change control procedures and completion of regulatory impact assessments for assigned commercial products.
- Ensure compliance with company policies, procedures and training expectations.
Required Knowledge, Skills, and Abilities
- Demonstrated understanding and strategic application of regulations and guidelines for drug development.
- Demonstrated knowledge of CMC regulatory and ability to generate clear, well-argued positions.
- Must have experience with electronic Common Technical Document CMC regulatory documents (MAA, BLA, variations, responses and CTAs/INDs).
- Demonstrated understanding of FDA, EMA and ICH guidelines.
- Exceptional interpersonal skills with the ability to work individually, within a multi-disciplinary team, as well as with external partners and regulators.
- Demonstrated ability to influence and impact their functional area and department practices.
Required/Preferred Education and Licenses
- BSc/BA with a minimum of eight years of regulatory CMC experience.
- English language - written and verbal communication skills.
Description of Work Environment
- Responsibilities may require a work schedule that may include working outside of “normal” work hours, in order to meet business demands.
Jazz Pharmaceuticals is an Equal Opportunity Employer.