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Senior Manager - Regulatory Affairs

Employer
Hyper Recruitment Solutions
Location
London
Salary
£70000 to £80000 per annum
Closing date
3 Apr 2019

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Job Details

A fantastic opportunity for an experienced Senior Regulatory Affairs Manager has become available within a developing Cell and Gene Therapy company based just outside of Greater London. You will report to the Director of Regulatory Affairs and will personally develop and implement regulatory strategy for current product development, Clinical Trail submission and for Marketing Authorisation Submission. This is a fantastic opportunity for Regulatory Affairs professionals that wants to join a developing Advanced Therapies company and play an integral part in the registration of novel therapeutics.

KEY DUTIES AND RESPONSIBILITIES:

Your duties as the Senior Manager of Regulatory Affairs with a focus on ATMP will be varied however the key duties and responsibilities are as follows:

1. Drive Regulatory strategy and operations in relation to product development and registration.

2. Prepare high quality regulatory documentation including but not limited to CTA / IND / IMPD, Scientific Advice briefing packages, PRIME applications, PIP / PSP, MAA / BLA as well as responses to questions by relevant agencies.

3. Liaise with Regulatory agencies including the MHRA, EMA and FDA for EU and US markets where you will act as the point of contact for submission of relevant documentation

4. You will maintain and up to date knowledge of Global Regulatory requirements for ATMP products including Clinical and CMC aspects.

ROLE REQUIREMENTS:

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

1. Relevant degree in a life sciences discipline (e.e Biology, Biochemistry, Biotechnology, Pharmacology etc.) with hands on experience in a Regulatory Affairs environment within a Biotechnology / Biologics and / or Rare disease industry.

2. Proven industry experience in a Regulatory Affairs setting where you are contributing to the early development of products through to the preparation of CTA / IND strategy and submission to MAA / BLA filings to EU and US markets.

3. Ability to plan and lead meetings with the FDA, EMA and European national regulatory authorities.

Key Words: Cell Therapy | Gene Therapy | Cell and Gene Therapy | ATMP | Biologics | Regulatory Affairs | IMPD | IND | CTD | MAA | EU | FDA | PIP | PRIME | Orphan Drug | Strategy | Lead | Management | Project Management | Biopharmaceutical | Pharmaceutical | Senior Manager

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for our talent development. We welcome applications for any applicant 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 processionals 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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