- Experience Level
- Experienced (non-manager)
A fantastic vacancy has become available for a Senior Regulatory Consultant in Surrey. This pharmaceutical regulatory affairs job is an excellent opportunity to work for a global leader in the life sciences industry.
- 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 Relevant Professional Qualifications desirable, (e.g. MSc in Regulatory Affairs) Previous experience and proven track record in Regulatory Affairs (Human Medicinal Products) Member of The Organisation for Professionals in Regulatory Affairs (TOPRA) preferred
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.