Job Reference: J5631444
Updated On: 07/05/2019
Status: Open to Applications
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Role OverviewWe are currently looking for a Regulatory Affairs Team Leader to join a leading EU Pharmaceutical company with an international presence based in the South Buckinghamshire area. As the Regulatory Affairs Team Leader you will be responsible for leading a medium sized Regulatory Affairs EU team and will act as the Deputy to the Head of Regulatory Affairs.
You will manage the day-to-day activity of the Regulatory department and ensure the successful and timely registration on new products in development as well as the life cycle management and geographical expansion of existing products.
Key Duties and ResponsibilitiesYour duties as the Regulatory Affairs Team Leader will be varied however the key duties and responsibilities are as follows:
1. Line manage 5+ Direct Reports where you will provide support and training through employee development plans, performance reviews and day to day management. You will be responsible for the recruitment into your team and ensure your staff follow EU Regulatory procedures.
2. Develop regulatory strategy for development projects and geographical expansion. You will lead the Marketing Authorisation (MA) maintenance activities to DCP, MRP and National Procedures, including the submission of Variations and Renewals.
3. You will be the main point of contact for regulatory agency interactions, including the preparation of briefing packages, strategy meetings and audits / inspections.
4. You will work cross functionally to ensure colleagues are kept up to date with EU regulatory legislation and influence internal key stakeholders on best regulatory practise.
Role RequirementsTo be successful in your application to this exciting opportunity as the Regulatory Affairs Team Leader we are looking to identify the following on your profile and past history:
1. Relevant degree in a Life Sciences discipline e.g Pharmacy, Pharmacology, Chemistry etc. in addition to extensive Regulatory Affairs experience with a focus on EU Regulations, Directives and Guidance.
2. Proven industry experience in of developing Regulatory Strategy for development and established products to EU markets including CP , DCP , MRP and National Procedures.
3. Experience of Line Managing a team of Regulatory professionals where you have recruited, developed, motivated and trained your team to a high standard through weekly, quarterly and yearly reviews.
Key Words: Line Management | Line Manager | Team Leader | Management | Regulatory Affairs | Strategy | EU Markets | CP | DCP | MRP | National procedures | Pharmaceutical | Manufacturing | Regulatory Agencies | MHRA | EMA
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