Regulatory Affairs Officer
- Employer
- Hyper Recruitment Solutions
- Location
- Berkshire
- Salary
- Dependent on Experience
- Closing date
- 16 Oct 2020
View more
- Sector
- Pharmaceutical, Regulatory Affairs
- Contract Type
- Permanent
- Hours
- Full Time
Job Details
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Regulatory Affairs Officer will be varied however the key duties and responsibilities are as follows:
1. Preparation and Submission of Marketing Authorisation Applications to MRP, DCP and National procedures.
2. Preparation and submission of product variations including Safety Variations, CMC Variations , Renewals and artwork and labelling changes.
3. Lead the Regulatory approval process for line extensions and life cycle management activities.
4. Work closely with the Regulatory Affairs Manager to ensure compliance of all regulatory activities and raise Change Controls as appropriate.
ROLE REQUIREMENTS:
To be successful in your application to this exciting opportunity as the Regulatory Affairs Officer we are looking to identify the following on your profile and past history:
1. Relevant degree in a Life Sciences discipline with previous Regulatory Affairs experience. Ideally looking for 2 years+ within the Pharmaceutical industry but OTC and Generics will also be considered.
2. Proven industry experience of handling Regulatory Submissions to UK and Ireland authorities, where experience of EU and Global markets would be beneficial.
3. A working knowledge and practical experience with Life cycle maintenance and post marketing authorisation is important where you have dealt with Health Authorities to negotiate and agree positive submissions.
Key Words: Regulatory Affairs | MAA | Post Marketing Authorisation | Life Cycle Management | Variations | Renewals | Submissions | EU | UK | Pharmaceutical | OTC | Genetic | Regulatory Affairs Officer
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
Facebook
Linked in
Google +
- Website
- http://www.hyperec.com/
- Telephone
- 0203 910 2980
- Location
-
Amshold House
Goldings Hill
Loughton,
Essex
IG102RW
GB
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