Description
Responsibilities: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 internal review and submission of these items.
Participate 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.
Manage EU, US commercial license maintenance.
Provide in-depth reviews of protocols, reports, presentations, and documents.
Manage CMC related regulatory agency interactions.
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 primary regulatory CMC representative at internal meetings as well as support at meetings with business partners and regulatory agencies for CMC related issues.
Monitor EU and US 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 quality verification of regulatory submissions.
Provide risk assessments and recommendations for various regulatory scenarios.
Requirements/Qualifications:
Ideally candidates will have an advanced degree in a relevant science discipline.
Must have at least 10+ years of pharmaceutical industry experience and 7+ years in Regulatory CMC.
Solid working knowledge of CMC regulatory and ability to generate clear, well-argued positions.
Must have experience with CMC regulatory documents (MAA, BLA, variations, responses and CTAs/INDs)
Knowledge of FDA, EMA and ICH guidelines.
Strong English language - written and verbal communication skills.
Demonstrated understanding and strategic application of regulations and guidelines for drug development.
Solid understanding of and experience with electronic Common Technical Document eCTD submissions.
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.
International travel will be a feature of this appointment.