Job Reference: J5631214
Updated On: 27/03/2019
Status: Now Interviewing
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Role OverviewHyper Recruitment Solutions are working in partnership with a Global Pharmaceutical company based in Buckinghamshire to identify a new Director of Regulatory Affairs to join and lead a team focused on the development and submission of novel Therapeutics. As the Director of Regulatory Affairs 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.
Our Senior Regulatory Affairs Consultant, Georgia Walden, would be interested in speaking with any Senior Regulatory professionals interested in this position with experience of the registration of new products or indications in European regions via CP, DCP, MRP. As well as someone with the ability to build and maintain relationship both internally and with Regulatory Agencies / Trade Associations with the ability to successfully leading a team.
Key Duties and ResponsibilitiesYour 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 of 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.
Role RequirementsTo 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. Experience of CMC documentation and project management would be of interest to see in your application.
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 | EU | EMEA | European Regulations | CP | MRP | DCP | MAA | CTA | Scientific Advise | CMC | CMC Maintenance | Renewals | Variations
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