Associate Director, Regulatory Affairs Global CMC
Category: Research & Development | Country: United States | State: Pennsylvania |City: Philadelphia | Type: Regular, Full Time | Job ID: 4384
Same Job Available In Three Locations
Philadelphia, Pennsylvania, United States
Palo Alto, California, United States
Jazz Pharmaceuticals is an international biopharmaceutical company focused on improving patients’ lives by identifying, developing and commercializing meaningful products that address unmet medical needs. We are continuing to expand our commercial product portfolio and our research and development pipeline in therapeutic areas that can leverage our unique expertise.
Our therapeutic areas of focus include sleep and hematology/oncology – areas in which we have a deep understanding of the patient journey and a suite of products and product candidates to address critical needs.
We are looking for the best and brightest talent to join our team. If you’re looking to be a part of a company with an unwavering commitment to improving patients’ lives and being a great place to work, we hope you’ll explore our career openings and get to know Jazz Pharmaceuticals.
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/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.