Regulatory Affairs, CMC Manager
|Job Title:||Regulatory Affairs, CMC Manager|
|Contact Name:||Gerry Kennedy|
|Job Published:||almost 3 years ago|
Our client is a fast growing highly profitable multinational biopharmaceutical company based in Dublin city.
This newly-created appointment will be responsible for supporting and managing registration and CMC regulatory support primarily for commercial and some development projects.
Participate as an active member of a multi-disciplinary team to execute Regulatory CMC strategies for commercial products, late, and early stage development programs. Activities including:
Manage ex US commercial licenses.
Planning, writing and reviewing regulatory submissions relating to (MAAs, NDAs, BLAs, meeting requests, and briefing documents Manage internal review and submission of these items.
Provide in-depth reviews of protocols, reports, presentations, and documents.
Managing and coordination of legalisation/Notary requirements for license changes for each territory
Involvement with Customer Services to ensure batch shipments comply with any current regulatory restrictions
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.
Monitor ex US 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.
Ideally candidates will have an advanced degree in a relevant science discipline
Must have at least 7+ years of pharmaceutical industry experience. Solid working knowledge of CMC regulatory and ability to generate clear, well-argued positions.
Should 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.
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.
Cv to Gerry Kennedy at The RFT Group at email@example.com 01 2302400 www.rftgroup.ie
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