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Senior CMC Regulatory Manager

Employer
Hyper Recruitment Solutions
Location
Hertfordshire
Salary
Industry Competitive Salary
Closing date
13 Jun 2019

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Sector
Manufacturing, Regulatory Affairs
Contract Type
Permanent
Hours
Full Time

Job Details

A fantastic opportunity for a CMC Regulatory Manager has opened within a rapidly growing Cell and Gene Therapy company based in the Hertfordshire area. As the Senior CMC Regulatory Manager you will develop the company's CMC regulatory strategy to ensure the successful development of life changing ATMP medicinal products.

KEY DUTIES AND RESPONSIBILITIES:

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

1. You will develop the CMC regulatory Strategy and use your extensive CMC experience to identify potential Regulatory challenges.

2. You will lead the preparation of CMC regulatory documentation ensuring timelines are maintained. You will work as part of a matrix team and gain insight for the scientific staff.

3. You will offer CMC regulatory guidance to the scientific staff and key stakeholders within the company and co-ordinate CMC focused meetings with regulatory agencies.

4. You will write CMC Regulatory documentation including but not limited to CMC question responses, CMC Scientific Advice briefing packages, Modules 2 and 3, PIP / PSP and PRIME.

ROLE REQUIREMENTS:

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

1. Relevant degree in a Life Sciences discipline (e.g. Biology, Biotechnology, Pharmacy, Pharmacology etc.) in addition to extensive CMC understanding and knowledge.

2. Proven industry experience in a CMC Regulatory setting, ideally within a Biotechnology, Biologics or Biopharmaceutical industry. This includes leading and advising on CMC regulatory strategy as well as hands on experience with CMC documentation writing.

3. A working knowledge and practical experience with Advanced Therapies would be a benefit to your application. Rare disease experience or novel therapeutic platform development is desirable.

Key Words: CMC | Regulatory Affairs | CMC Manager | Module 3 | Biologics | ATMP | Rare Disease | Gene Therapy | AAV vectors | CMC Documentation

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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