This commercial stage pharmaceutical organisation focusses on developing and delivering innovative new treatments to help improve the lives of patients with rare or orphan diseases. This organisation is committed to building a diversified portfolio of commercially attractive, best in class, proprietary new drugs to address some of these rare and debilitating illnesses. The organisation's leadership team boasts a wealth of experience in identifying, commercialising and delivering new treatments across global markets and it's this success that is driving the organisation's expansion at the business Corporate Offices here in Dublin and the need for a Global Regulatory Affairs CMC Manager has arisen to join their growing RA Division.
- 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
To learn more about this role apply online or contact Shane Browne on + 353 1 6321865 for a confidential discussion.