The Regulatory Professional provides support to the EMEA Regulatory Liaison (EURL)/EMEA Regional Therapeutic Area Leader and/or Global Regulatory Leader (GRL) for regulatory activities for products in the assigned portfolio.
Key responsibilities include the following:
- Input in development, post-approval and life cycle management
- Liaison with Regulatory Agencies and Local Operating Companies
- Input in document and process development
- Clinical Trial Applications (CTA)
- Marketing Authorization Applications (MAA)
- Responsible for assigned projects to ensure strategic regulatory alignment across all functional areas.
- Supports all regulatory activities associated with the development, post-approval and life-cycle management for designated products. Provides regulatory strategic and operational support for products by interacting with project teams, LOCs and regulatory agencies (as appropriate) and supporting CTA and MAA related submissions as appropriate.
- Provide other general support on an as needed basis e.g. provide regulatory input and follow-up for inspections, audits, litigation support and products complaints (as appropriate)
- Provides guidance and support to product development teams on regulatory issues
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Peter Duvall on +44 203 0789 542 or upload your CV on our website www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.