ProClinical is currently recruiting for a Regulatroy Affairs Senior Manager job at a leading multinational biopharmaceutical company with leading therapies in autoimmune diseases and oncology. They are seeking an individual to bring solid regulatory affairs experience their team at their offices in Uxbridge, UK. This is an exciting opportunity to work for one of the world's biggest biotechnology firms that employs over 17,000 staff globally. The RA Senior Manager position entails ensuring that the company acquires and maintains all the required licenses to support clinical trials for investigational medicinal products as well as to market approved medicinal products
- Advising the GRT on regional considerations in developing strategy
- This role will support one or more products from a regional regulatory perspective. As a member of the Global Regulatory Team (GRT), they will achieve the desired labelling by developing and executing regional regulatory strategies and managing effective agency interactions.
- Ensuring the regional needs are well defined and implemented in collaboration with relevant regional stakeholders
- May manage one or more regional leads or support roles Strategy and Execution Plans and manages regulatory submissions (e.g. clinical trial and marketing applications) for products within the company’s portfolio in compliance with global filing plans and local regulatory requirements.
- Implements product related regulatory strategies, Regulatory Affairs processes and activity planning in accordance with national legislation and regulatory requirements.
- Leads development of regional regulatory documents and meetings in accordance with GRT strategy
- Provides regulatory direction on regional regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, conditional/accelerated approvals, compassionate use and paediatric plan)
- Directs the development of the regional product label by collaborating with the Labelling Working Group to define commercial objectives in the context of available and expected scientific data, regulatory guidance and precedent.
- Manages regional label negotiation activities
- With minimal supervision, participate in the development and execution of regional regulatory product strategies, including precedence, risk management and contingency planning
- Consistent with GRT strategy, advise GDT on regulatory implications and requirements related to global clinical development plans and objectives
- Co-ordinates company responses to requests from regulatory authorities, e.g Response to Questions (RTQs)
- Communicates regulatory strategies as appropriate such that expectations are understood.
- Estimate the likelihood of regulatory success based on proposed strategies and discuss with GRT and line Management
- Develop predictions for expectations and risks associated with outcomes by regulatory agencies
- Ensure regulatory product compliance for product (e.g. IMR, PMCs, paediatric and other agency commitments) collaboration
Skills and Requirements:
- Knowledge and Skills Regulatory knowledge in regional legislation Working with policies, procedures and SOPs
- Experience with national legislation and regulations relating to medicinal products
- Understanding of the regional regulatory procedures for CTAs, MAs, post approval changes, extensions and renewals.
- Understanding of drug development Scientific / Technical Excellence
- Strong knowledge of and experience in regional regulatory environment in relevant product area and development stage
- Comprehensive understanding of regulatory activities, touch points and how they affect projects and processes
- Ability to resolve conflicts and develop a course of action leading to a beneficial outcome
- Cultural awareness and sensitivity to achieve results across both regional country and International borders.
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 Numhom Sudsok on +44 203 8718 093 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.