Role: Regulatory Affairs CMC Manager
Location: Dublin
Employment: Permanent, Full Time
Company
Our 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 regulations
If you are interested in discussing this role further, then please email your CV to [email protected] 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*.