Regulatory Affairs Global CMC Senior Manager

Job Spec

• 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 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.

• 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.
• BSc/BA with a minimum of five years of regulatory CMC experience.
• English language - written and verbal communication skills.
• Work indoors in normal office environment with little exposure to excessive noise, dust, fumes, vibrations and temperature changes.
• 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.