The Associate Director / Manager, Regulatory Affairs Global CMC will be responsible for managing registration and CMC regulatory support for commercial and development projects worldwide.
Job Spec :
Activities including planning, writing and reviewing Module 2 and 3 CTD sections of all regulatory submissions (INDs, IMPDs, CTAs, MAAs, NDAs, BLAs, meeting requests, and briefing documents). Manage the internal review and submission of these items.
Participate and support as an active member of a multi-disciplinary team to establish development and Regulatory CMC strategies for commercial products, late, and early stage development programs. Identify and communicate potential risks associated with strategy scenarios.
Support EU, US and global clinical trials and commercial license maintenance.
Provide reviews of protocols, reports, presentations, and documents.
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 internal meetings as well as support 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 change control procedure.
Participate in the electronic publishing and quality verification of regulatory submissions.
Provide risk assessments and recommendations for various regulatory scenarios
Demonstrated understanding and strategic application of regulations and guidelines for drug development.
Solid understanding of and experience with electronic Common Technical Document eCTD submissions.
Solid working knowledge of CMC regulatory and ability to generate clear, well-argued positions.
Must have experience with CMC regulatory documents (MAA, BLA, NDA, variations, responses and CTAs/INDs).
Knowledge of FDA, EMA and ICH guidelines.
Ability to work independently; willingness to voice opinions in the group environment.
Exceptional interpersonal skills with the ability to work individually, within a multi-disciplinary team, as well as with
external partners and regulators.
Some travel required.
Required/Preferred Education and Licenses
BSc/BA with a minimum of five years of regulatory CMC experience.
English language - written and verbal communication skills.
Responsibilities may require working outside of "normal" hours, in order to meet business demands.