This is a rare opportunity to join one of the most exciting young global biopharmaceutical companies, headquartered here in Dublin. With a rich development and commercial pipeline our client is focussed on rare and orphan diseases.
The newly created position of Regulatory Affairs CMC Manager will report to the Head of Regulatory Affairs. You will possess CMC regulatory knowledge and quality expertise to independently prepare regulatory assessments and author CMC regulatory documentation and contribute to global regulatory strategies for projects across all aspects of drug development or manufacturing lifecycle.
- Participate as the CMC representative on core projects and advise on CMC regulatory strategies for programs in accordance with regulatory, scientific & technical criteria.
- Assist in developing and implementing strategies for the earliest possible approvals of regulatory submissions.
- Ability 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.
- With minimal supervision, 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.
- Participate on project teams and provide expertise on CMC regulatory matters.
- Prioritise and independently complete assigned workload appropriately.
- Develop and maintain current regulatory knowledge and awareness of new scientific or manufacturing technology and advise management of significant developments.
- Bachelor’s degree or equivalent/graduate degree preferred in a pharmaceutical (Biology, Chemistry, Pharmacy or related science).
- 5+ years of experience in regulatory affairs within the pharmaceutical or biotechnology industry; experience with biological products a distinct advantage.
- Experience and knowledge in preparation of CMC sections of IMPD, IND, MAA, NDA, and supportive amendments and supplements. Experience with CTD/eCTD.
- A minimum of 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.
- Experience of dealing with regulatory agencies is preferred.
- Sufficient level of knowledge and solid understanding of the development and commercial activities and cGMP’s required to assess technical, scientific and regulatory merits of CMC information, commitments and data to advise teams and/or project(s).
- An understanding of regulatory requirements and expectations, criteria for submission and approval globally.
- Prior experience managing projects is preferred.
- Outstanding written and verbal communication skills.