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Regulatory Affairs Manager

Employer
Hyper Recruitment Solutions
Location
Hitchin
Salary
Dependent on experience
Closing date
12 Feb 2021

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Job Details

Are you an experienced Regulatory Affairs Manager looking for a new exciting job opportunity?

We are currently looking for a Regulatory Affairs Manager to join a leading pharmaceutical company based in the Hertfordshire area.

As the Regulatory Affairs Manager you will be responsible for providing comprehensive and broad-ranging regulatory expertise and management in all aspects of obtaining and maintaining market authorisations and other regulatory registrations/permits required by the company.


KEY DUTIES AND RESPONSIBILITIES:

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

1. You will be responsible for providing regulatory strategy expertise in New Product Development, product maintenance as well as regulatory support to clinical development. Your role will include regulatory compliance guidance and support to other departments with a particular focus on CMC.

2. You will also be responsible for planning, organising and as necessary compiling and submitting applications for clinical trials, marketing authorisations, registrations, technical files, manufacturing authorisations as well as wholesale dealer's authorisations.

3. As the Regulatory Affairs Manager, you will be responsible for preparing and maintaining additional supporting regulatory documentation including product literature and technical reports.

4. Additionally, you will assist in reviewing labelling, advertising copy in accordance with regulatory standards as well as training and developing the regulatory team.

ROLE REQUIREMENTS:

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

1. Proven relevant regulatory experience in medicines and experience in CMC is essential for this role, as there is a significant emphasis on technical aspects in the role (Modules 3).

2. As well as experience with medicines, regulatory experience in medical devices or cosmetics would be preferred and highly advantageous.

3. Ability to identify commercially effective approaches to regulatory problems and find innovative solutions, meticulous attention to detail, experience of document management systems and NeeS/eCTD submission is also required for this role.

Key Words: Regulatory Affairs Manager | Regulatory Specialist | CMC | Manufacturing | Pharmaceutical | Clinical Affairs | Cosmetics | Medical Devices

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: 
Twitter
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Company info
Website
Telephone
0203 910 2980
Location
Amshold House
Goldings Hill
Loughton,
Essex
IG102RW
GB

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