Associate Director - Regulatory Affairs CMC

Associate Director – Regulatory Affairs CMC

Experience with preparing INDs, IMPDs, NDA and/or MAA submission(s) is essential.
Strong knowledge and experience in the writing and the overall preparation of CMC sections of regulatory submissions.
BS or equivalent with 10+ years of related experience.

Serves as regulatory CMC lead for assigned product(s) for all regulatory CMC responsibilities, including, but not limited to, the development and implementation of regulatory CMC strategy for assigned projects.
Prepares and reviews submission-ready CMC and marketing registration applications, supplements, amendments, and variations.
As a member of the project teams, provides CMC regulatory guidance for global development and registration programs (e.g. INDs, CTAs, NDAs and MAAs).
Assesses and communicates CMC regulatory requirements to ensure all development activities are in compliance with applicable regulations and guidelines.
Serves as regulatory representative for assigned projects at internal meetings as well as at meetings with regulatory agencies for all CMC related issues.
Manages and ensures compliance with all reporting requirements, including annual and periodic reports.
Maintains knowledge of relevant evolving regulation and guidance.
Key contributor to establish and implement regulatory strategy within Global Regulatory Teams.
Represents Sarepta as direct contact for FDA and at global health authority meetings including assisting planning, preparation for and conduct of meetings with Regulatory agencies for all assigned products.
Interacts across levels and line functions to lead team through successful engagements with Health Authorities.