This innovative Irish biopharmaceutical client are seeking an experienced Senior Regulatory Affairs CMC Specialist to join the regulatory team at their Dublin headquarters. This organisation develop products focused on rare and genetic diseases, and have robust pipeline of late stage clinical products. Having recently signed off on an exciting acquisition, they are going from strength to strength. This is a permanent opportunity with a hybrid working model available.
The Senior Regulatory Affairs CMC Specialist will manage the regulatory change controls related to CMC updates to global and regional dossiers across a product portfolio. This role interacts cross functionally to ensure alignment on CMC submissions scope and timelines to meet the corporate goals and compliance requirements.
Duties and responsibilities of the Senior Regulatory Affairs CMC Specialist will include but are not limited to:
- 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.
You will have skills and experience in the following:
- BSc or graduate degree in life sciences
- 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.
- Proficiency in the use of Trackwise and document authoring systems (e.g., RCAM/Documentum)
- Excellent written communication skills/technical writing experience
To discover more about this opportunity, apply now or contact Maeve Fahey at HRM on +353 1 632 1885 for a confidential discussion.