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Regulatory Affairs CMC Manager

Employer
Hyper Recruitment Solutions
Location
Hertfordshire
Salary
Competitive Salary
Closing date
21 May 2019

Job Details

We are currently looking for a Regulatory Affairs Manager to join a leading Pharmaceutical Company based in Hertfordshire. This is an exciting opportunity for a Regulatory Affairs Professional who is looking to take ownership of their own activities as well as expand their skills set into Project Management of client API Manufacturing projects.

As the Regulatory Affairs CMC Manage ryou will spend the majority of your time maintaining current registrations as well as ensuring the new registration of Active Pharmaceutical Ingredients but will also speak with and manage client projects.

KEY DUTIES AND RESPONSIBILITIES:

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

1. Manage the Life cycle for existing API products including the review, editing and submission the required documentation.

2. Work cross functionally to support the generation of information for new ASMF (Active Substance Master Files) and DMF (Drug Master Files).

3. Ensure that all staff are trained to support ASMP and CEP submissions.

4. Manage new API client projects and ensure that specific project timelines are met.

ROLE REQUIREMENTS:

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

1. Relevant degree in a Life Sciences discipline (e.g. Chemistry, Pharmacology, Pharmacy etc.) in addition to some experience of working in a Regulatory Affairs environment.

2. Ideally, industry experience in the Manufacturing of API's and will as experience of the Regulatory activities in relation to the registration of ASMF within EU, US and RoW regions. Extensive CMC writing experience will be considered.

3. A working knowledge and practical experience working with the EDQM to obtain a CEP will be beneficial in your application.

Key Words: Regulatory Affairs | Project Manager | Project Management | CMC | API | ASMF | CEP | ASMF registration | API Registration | EDQM | Pharmaceutical | Herbal | Botanical | Life Cycle Management | Variations | Renewals

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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