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Senior Regulatory Affairs CMC Specialist

Location: Dublin City Centre, Dublin
Salary: Negotiable
Posted: about 2 months ago
Role type: Permanent
Industry: Life Sciences & Engineering Practice, Science Leaders & Specialists
Contact name: Helena Boyle
Contact email: helena.boyle@hrmrecruit.com

Job description

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.

The Role

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.

The Person

  • 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.

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Helena Boyle

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