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Senior Regulatory Affairs Officer

Employer
Hyper Recruitment Solutions
Location
Hertfordshire
Salary
Competitive
Closing date
23 Jul 2019

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Job Details

We are currently looking for a Senior Regulatory Affairs Officer to join a leading Biotherapeutics company based in the Hertfordshire area. As the Senior Regulatory Affairs Officer you will participate in the Regulatory strategy generation for Marketing Authorisations for new products and region expansions.

You will have the opportunity to join a long standing Biopharmaceutical company with an innovative range of Biotherapeutics. You will join a small team where you will have to opportunity to work on Orphan Drug products and use your knowledge of EU regulatory procedures to project manage products from submission, to approval and all the way through to launch.

KEY DUTIES AND RESPONSIBILITIES:

Your duties as the Senior Regulatory Affairs Officer will be varied however the key duties and responsibilities are as follows:

1. Develop product licensing strategies for new products and new markets as well as maintaining existing licences through variation and renewal activities.

2. Manage the regulatory aspects and licensing of Orphan Drugs within the US, EU and/or Intercontinental countries where you will communicate directly with the MHRA and other health authorities to gain advice, guidance or clarification of legal issues or submission processes.

3. Communicate directly with relevant internal departments including the manufacturing team to ensure all documentation is generated correctly.

4. You will deputies the Regulatory Affairs Manager in their absence.

ROLE REQUIREMENTS:

To be successful in your application to this exciting opportunity as the Senior Regulatory Affairs Officer we are looking to identify the following on your profile and past history:

1. Relevant degree in a Life Sciences discipline (e.g. Biology, Chemistry, Pharmacology, Pharmacy etc.) in addition to experience in a Regulatory Affairs function where you have been involved in licensing activities. Experience of Orphan Drug classifications and licensing procedures will benefit your application.

2. Proven industry experience in with EU procedures (CP, MRP, DCP and National) for drug development through to product launch in addition to experience of managing post approval activities.

3. A working knowledge and practical experience with Biological Licence Applications (BLA) to the FDA in the US will be beneficial to your application.

Key Words: Regulatory Affairs | MAA | Marketing Authorisation Application | BLA | Biological Licence Application | MHRA | EMA | FDA | Orphan Drug | Drug Development | Licence Submission | Life Cycle Management | Post Marketing Activities | eCTD

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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