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Regulatory Affairs CMC Consultant

Employer
Hyper Recruitment Solutions
Location
United Kingdom
Salary
£412 - £525 per day
Closing date
21 Jan 2021

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Job Details

We are currently looking for a Regulatory Affairs Consultant to join a leading Pharmaceutical company based in the South East of the UK, on a 12 month contract. As the Regulatory Affairs Consultant you will be responsible for supporting and executing Regulatory Affairs CMC submissions, as well as developing Regulatory Affairs CMC strategy. This is a fantastic opportunity for an experienced Regulatory Affairs CMC Specialist to join a leading business with strong product pipeline. This role is a 12 month contract and offers home working during the Covid-19 pandemic.

KEY DUTIES AND RESPONSIBILITIES:

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

1. Support on CMC RA Strategy and ensure these are delivered on time and as per project timelines.

2. Execute CMC submissions in liaison with a variety of functions (Most notably the Global RA CMC Lead)

3. The Regulatory Affairs Consultant will be proactive in recognising potential issues throughout product lifecycle, ensuring these are identified are rectified as soon as possible.

4. Contribute towards Regulatory Risk Assessments by identifying possible strengths and weaknesses within the businesses product portfolio.

ROLE REQUIREMENTS:

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

1. Relevant degree in a Scientific or Pharmaceutical Discipline

2. Proven industry experience working as a Regulatory Affairs CMC Specialist or point of contact (Biotechnology/Biologics product experience would be ideal)

3. A working knowledge and practical experience with preparing and executing Regulatory CMC documentation, as part of Marketing Authorisations.


Key Words: Pharmaceutical / Regulatory Affairs / RA / Reg Affairs / Regulatory / CMC / Module 3 / GMP / Biologics / Contract / Contractor / Consultant / RA Consultant / Regulatory Affairs Consultant / Biological / Biotech / Biotechnology

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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