Regulatory Consultant - CTA
A fantastic vacancy has become available for a Senior Regulatory Consultant working remotely from home. You will need to be able to support Clinical trials, providing regulatory expertise.
- Provide regulatory input to commercial strategic and operating planning process.
- Attend relevant product team meetings with cross-divisional colleagues to provide technical guidance and support for teams as necessary.
- Work with above country regulatory strategists (AC-RS) to provide country input into Global and European Regulatory Strategies as required.
- Seek to improve alignment of local and regional regulatory strategy and tactics.
- Use expert knowledge of EU/national legislation, guidelines, regulatory environment to provide insightful responses to enquiries from cross-divisional colleagues and direct or indirect interactions with external customers.
- Manage and Submit Marketing Authorisation Applications: National/MRP/Decentralised MAA:
- Manage and Submit MA Variation Applications
- Prepare agreed Module 1 documents in partnership with above-country operational hubs. Lead MRP/DCP submission review and planning where country is RMS, in conjunction with AC-RS
- Proactively take opportunities to develop or enhance working relationships with Regulatory Authorities and trade associations.
- Manage Clinical Trial Approvals (if performed in country
Skills and Requirements
- Life sciences or chemistry graduate to honours level or equivalent
- Master's Degree, Post Graduate Diploma or PhD preferred
- Previous experience and proven track record in Regulatory Affairs
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.