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Director of Regulatory Affairs

Employer
Hyper Recruitment Solutions
Location
Buckinghamshire
Salary
Negotiable
Closing date
24 Apr 2019

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Job Details

Hyper 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 RESPONSIBILITIES:

Your duties as the Director of Regulatory Affairs 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 REQUIREMENTS:

To be successful in your application to this exciting opportunity as the Director of Regulatory Affairs 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

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.

Company

Hyper Recruitment Solutions is a specialist and highly compliant recruitment consultancy dedicated to the Science and Technology sectors.

Hyper Recruitment Solutions (HRS), founded and run by Ricky Martin and in partnership with Lord Alan Sugar, has a wealth of recruitment expertise as well as compliance and commercial awareness. We offer a range of permanent, temporary and contract staff.

Our vision is to provide recruitment solutions which will assist in the improvement and quality of life for all. To do so, HRS will focus on the support of sectors whose primary focus is in making the world a better place. This could be working for a Pharmaceutical company who is developing new and existing therapeutics or an FMCG business who is making the latest consumer products in a sustainable and efficient way. We want to provide a service to those areas of actual need which will have an impact on us all.

We provide services across a broad range of industries including the following specialist sectors:

• Biotechnology
• Pharmaceutical
• Medical Device
• Clinical Research
• CMO / CRO
• Food / FMCG
• Engineering
• Science

With all jobseekers we are looking to form close relationships where we can offer you the most accurate and useful advice. We intend to not only find and present the most ideal career options to you, but we want to provide advice on the entire recruitment process. We are a business who listens and advises and as shown on our website we have a clear ‘candidate commitment’ to ensure your search is in the most professional and capable hands. Some of the key areas we focus on include:


• Quality Assurance (including Qualified Persons)
• Clinical Research (all phases and therapeutic fields)
• Bioinformatics
• Research & Development
• Consumer Insight and Sensory
• Lean and Continuous Improvement
• Engineering (all disciplines)
• Manufacturing, Scale up and Technology Transfer
• Packaging and Sustainability 
• Medical Affairs
• Sales and Business Development
• Information Systems & Technology
• Executive Appointments


HRS has been awarded membership to the REC (Recruitment and Employment Confederation) and APSCo (Association of Professional Staffing Companies). This is to assure all clients and candidates that our processes and practices comply with all relevant government and recruitment industry regulations.

Lord Sugar, Ricky Martin and everyone at HRS look forward to working with you. Please do not hesitate to visit our website www.hyperec.com or contact us via
Telephone: 02032 255 120
Email:info@hyperec.com


Or any of the social media routes below: 
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Company info
Website
Telephone
0203 910 2980
Location
Amshold House
Goldings Hill
Loughton,
Essex
IG102RW
GB

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