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 regulatory submissions as assigned (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.