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Senior Regulatory Affairs Officer

Employer
Hyper Recruitment Solutions
Location
Berkshire
Salary
Dependent on Experience
Closing date
16 Oct 2020

Job Details

We are currently looking for a Senior Regulatory Affairs Officer to join a leading Global Pharmaceutical company based in the Berkshire. As the Senior Regulatory Affairs Officer you will be responsible for a range of regulatory activities in product submission, life cycle management of in-licensed and Generic CNS products as well as Regulatory compliance.

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. Assist with the preparation, submission and coordination of Marketing Authorisation Applications in accordance with EU requirements through Mutual Recognition and Decentralised procedures. You will finalise the national phases by generating Patient Information Leaflets, product labelling and artwork.

2. You will compile and submit product variations and renewals in line with DCP , MRP and National procedures. You will also have exposure to regulatory operations through compiling in eCTD and NeeS format.

3. You will liaise with 3rd party Manufacturers to ensure you have the correct documentation and to ensure the right licenses are obtained.

4. You will ensure the company remains compliant in terms of Regulatory activities. You will ensure documentation is appropriately stored and managed and raise change controls as required.

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. Pharmacology, Chemistry, Biology etc.) in addition to experience in a Regulatory Affairs focused position, ideally with EU experience.

2. Proven industry experience of Regulatory Submissions to Global authorities including new MAA and Life-cycle management as well as experience with negotiating positive outcomes with Health Authorities

3. A working knowledge and practical experience with the preparation of MAA, variations and renewals for MRP and DC procedures.

Key Words: Regulatory Affairs | Associate | Officer | Marketing Authorisation Applications | MAA | Mutual Recognition Procedures | MRP | Decentralised Procedures | DCP | eCTD | NeeS

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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