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We are currently looking for a Regulatory Affairs Director to join a leading Global Pharmaceutical company based in the Buckinghamshire area. As the Regulatory Affairs Director - Europe you will be responsible for defining and implementing regulatory strategy within European Markets for products at Drug Development, New Product Submission and Life Cycle management stages.
You will be responsible for a team of up to 10 Regulatory Professionals and ensure they adhere to the EU strategy that you set, in line with Global Regulatory Strategy plans.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Regulatory Affairs Director - Europe will be varied however the key duties and responsibilities are as follows:
1. You will develop and lead the Regulatory Strategy for your therapeutic area and provide European regulatory input to Global Regulatory Teams including input for commercial products as well as late and early stage development programs, ensuring all strategy aligns with European guidelines.
2. Supervise activities including the planning and co-ordination of the writing and reviewing all regulatory submissions (CTAs, MAAs, meeting requests, and briefing documents) in addition to supporting product launches and post marketing activities (Renewals, CMC Maintenance, Labelling and packaging changes as well as Pricing and reimbursement activities).
3. Ensure the effective management of your team including training and developing of staff with ongoing performance reviews and addressing issues as required. You will manage your permanent and contingent headcount and recruit as required.
4. Lead Regulatory compliance, ensuring processes (SOPs) and best practise guidelines are adhered to. You will also effectively manage budgets in line with corporate strategy.
To be successful in your application to this exciting opportunity as the Regulatory Affairs Director - Europe we are looking to identify the following on your profile and past history:
1. Life Sciences Graduate ideally with a post-graduate qualification and/or experience within a product development function of Pharmaceuticals / Biopharmaceuticals.
2. Proven industry experience of European Pharmaceutical Regulations with a proven track record of developing EU strategy for products at Development, Submission and Lifecycle stages.
3. Experience of Line Management of Regulatory professionals as well as project team leadership.
4. Excellent organisational and planning ability with a proven track record of negotiation skills both with internal stakeholders and external Regulatory Bodies and Vendors.
Key Words: Regulatory Affairs | Director | Line Management | Line Manager | Strategy | Development | Pharmaceuticals | Biopharmaceutical | Clinical | Toxicology | European Regulations | CP | MRP | DCP | MAA | CTA | Scientific Advise |
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for talent development. We therefore welcome applications for any interested parties who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment professionals and scientists. We look forward to helping you with your next career moves.