My client is a specialist biopharmaceutical company focused on developing and delivering innovative new treatments to help improve the lives of patients with rare and orphan diseases. The company comprises of a growing commercial business and a significant development pipeline and there is now an opening for a new Senior Regulatory Affairs CMC Specialist with their Dublin team.
Reporting to the Regulatory Affairs CMC Manager, this role has several duties and responsibilities:
- In collaboration with manufacturing and quality colleagues maintains trackers for planned CMC variations/annual reporting and post-approval CMC and manufacturing commitments.
- Supports the regulatory CMC activities by drafting CMC CTD related content consistent with approved manufacturing changes and procedural requirements.
- Manages requests for EMA Certificate of Medicinal Product (CMP) and FDA Certificate of Pharmaceutical Product (CPPs).
- Project manage regulatory CMC timelines and stakeholder inputs to meet submission goals.
- Supports CMC authoring for FDA submissions such as Annual Reports and Lot Distribution.
- Maintains compliance tracker and updates for core, global and regional CMC registration details.
- Performs QC of CMC regulatory submission documents to ensure complete and accurate regulatory filings based on source data.
- Provides guidance regarding technical content and structure requirements for CMC documents.
- BSc in a life science subject.
- 3+ years' experience in a regulatory affairs role, with CMC and Labelling experience.
- Demonstrated understanding of pharmaceutical/biopharmaceutical manufacturing processes.
- Ability to effectively prioritise and manage competing priorities.
- Proven experience of working collaboratively within global teams and cross functionally across an organisation.
Contact Helena Boyle on (01) 6321870 for a confidential discussion.