The Senior Manager, Regulatory Affairs Global CMC will be responsible for managing registration and CMC regulatory support for commercial and development projects worldwide.Essential Functions
Required Knowledge, Skills, and Abilities
- Planning and co-ordination of the writing and reviewing for Module 2 and 3 CTD sections of all regulatory submissions (INDs, IMPDs, CTAs, MAAs, NDAs, BLAs, meeting requests, and briefing documents).
- Participate and support as an active member of a multi-disciplinary team to establish Regulatory CMC strategies for commercial products, late and early stage development programs, under the supervision of GRA-CMC leadership.
- Through the performance of risk assessments, work with GRA-CMC leadership to identify and communicate potential risks associated with strategy scenarios to the a multi-disciplinary team.
- Support EU, US and global clinical trials and commercial license maintenance.
- Coordinate the preparation and timely submission of responses to regulatory agencies. Manage timelines to ensure approvals are timely and development objectives are met.
- Act as regulatory CMC representative at meetings with business partners and regulatory agencies for CMC related issues.
- Monitor Global 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.
- Verify electronic publishing of regulatory submissions.
- Support GRA-CMC team projects for module 3 writing or health authority responses, as required.
- Identify & support continuous improvement opportunities for the GRA-CMC team and the broader GRA team.
- Ensure compliance with company policies, procedures and training expectations.
Required/Preferred Education and Licenses
- Demonstrated understanding and strategic application of regulations and guidelines for drug development.
- Solid working 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.
Description of Physical Demands
- BSc/BA with a minimum of five years of regulatory CMC experience.
- English language - written and verbal communication skills.
Description of Work Environment
- Occasional mobility within office environment.
- Routinely sitting for extended periods of time.
- Constantly operating a computer, printer, telephone and other similar office machinery.
- Some travel required.
- Work indoors in normal office environment with little exposure to excessive noise, dust, fumes, vibrations and temperature changes.
- Frequent computer use at workstation.
- May move from one work location to another occasionally.
- Responsibilities may require a work schedule that may include working outside of “normal” work hours, in order to meet business demands.
- Occasional public contact requiring appropriate business apparel.
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.