Regulatory Affairs CMC Manager in London - Cpl Life Sciences

Job Overview

London, England
Job Type
Full Time
Date Posted
9 days ago

Additional Details

Job ID
Job Views

Job Description

Role: Regulatory Affairs CMC ManagerLocation: DublinEmployment: Permanent, Full TimeCompanyOur client is a global biopharmaceutical company focused on developing and delivering innovative new treatments to help improve the lives of patients with rare and orphan diseases. They are a growing commercial business with a significant development pipeline. Maybe a little bit more on the what the position will be? Ie Working as a Regulatory Affairs CMC Manager, you will reporting into the Head of Regulatory support CMC activities and contributing to global regulatory strategies.Main responsibilities• Contribute as the CMC representative on core projects and advise on CMC regulatory strategies for programs in accordance with regulatory, scientific & technical criteria.• Support in developing and implementing strategies for the earliest possible approvals of regulatory submissions. • Capability to identify and present issues for resolution, communicate regularly with key stakeholders to ensure alignment on CMC regulatory issues.• Maintain CMC related submission information in the relevant systems, track regulatory commitments and timelines for specific projects/products/markets.• Plan, author and manage the assembly and timely submission of CMC related sections of IMPDs, INDs, NDAs, MAAs, post approval, renewal, line extensions and other dossiers to meet filing requirements. • Coordinate and contribute to responses to Agency queries.• Ensure regulatory submissions are maintained in compliance with regulatory requirements.Knowledge, Experience & Skills:• Eligibility to work in the EU • Bachelor’s degree or equivalent/graduate degree preferred in a pharmaceutical (Biology, Chemistry, Pharmacy or related science).• Ideally 5+ years of experience in regulatory affairs within the pharmaceutical or biotechnology industry• Experience and knowledge in preparation of CMC sections of IMPD, IND, MAA, NDA, and supportive amendments and supplements. Experience with CTD/eCTD.• Ideally 3+ years of hands-on CMC authoring experience (initial registrations or post-approval variations) is preferred.• Working knowledge of EMA, FDA and ICH regulatory guidance and regulationsIf you are interested in discussing this role further, then please email your CV to or call Amani on 01189 522 797 to arrange a confidential discussion.If you are not currently looking but know someone who would be good for this role then get in touch. We offer a referral scheme at Regulatory Professionals where in which a successful recommendation will earn you 250 worth of vouchers *terms and conditions apply*.Job type("FULL_TIME")


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