This opportunity is available in Dublin, Ireland.
The Senior Manager, Regulatory Affairs Global CMC will be responsible for managing registration and CMC regulatory support for commercial and development projects worldwide.
- 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 Knowledge, Skills, and Abilities
- 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.
Required/Preferred Education and Licenses
- BSc/BA with a minimum of five years of regulatory CMC experience.
- English language - written and verbal communication skills.
Description of Physical Demands
- 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.
Description of Work Environment
- 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 Employer.