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Director of Regulatory Affairs

Employer
Hyper Recruitment Solutions
Location
Salisbury
Salary
Experience Dependent
Closing date
5 Sep 2019

Job Details

We are currently looking for a Director of Regulatory Affairs to join a leading Biopharmaceutical company based in the Wiltshire area. As the Director of Regulatory Affairs you will be responsible for working alongside the companies Managing Director to be the regulatory expert and lead, manage and direct all aspects of the companies regulatory strategy. This is an executive level appointment and it is expected you will be commercially aware of the bioprocess industry, advising on the best path of growth for the business and future commercialisation options.

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. Manage and maintain regulatory licences and approvals relating to manufacture, testing and distribution of medicinal products. Be the companies expert point of contact for regulatory authorities, customers, UK Government Departments on regulatory affairs

2. Develop and add to the current Regulatory Team to ensure the business can deliver on all strategic plans and ensure you respond to all matters related to the relevant regulatory authority.

3. As the Director of Regulatory Affairs you will be an executive in the company you will contribute fully to the development of company strategy across all areas of the business, challenging assumptions and decision-making as appropriate and providing regulatory focussed analysis and guidance on all activities, plans, targets and business drivers. This will involve presenting at company board meetings.

4. As part of your executive role you will co-ordinate commercial negotiations with customers in order to achieve project objectives, secure optimal cost recovery and protect intellectual property in accordance with company goals.

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 history:

1. Relevant degree (PhD preferable but not essential) in a life sciences discipline (i.e. Biochemistry, Chemistry, Pharmaceutical Management, Biological Sciences etc) with proven experience in leading a team to set and deliver the EU regulatory strategy related to biopharmaceutical product.

2. Proven industry experience operating at an executive level within a Biopharmaceutical business, pharmaceutical licensing procedures and pharmacovigilance reporting in the UK, EU and USA. You would also have a working knowledge of IMP licensing and clinical trial management.

3. A working knowledge and practical experience with UK/EU legislation associated with manufacture of pharmaceuticals and FDA 21CFR 210 & 211 is expected.

Key Words: Director of Regulatory Affairs / Regulatory Leadership / Biopharmaceutical / GMP / EU Regulatory Affairs / Executive Appointment / Senior Leadership Team /

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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