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Senior CMC Regulatory Compliance Team lead

Employer
Hyper Recruitment Solutions
Location
Hertfordshire
Salary
Not specified
Closing date
4 Aug 2021

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Job Details

We are currently looking for a Senior CMC Regulatory Compliance Lead (Regulatory Affairs) to join a leading Life Sciences company based in the Hertfordshire area. As the Senior CMC Regulatory Compliance Llead you will be responsible for Technical Documentation Control and Planning within the Regulatory Affairs Group. You will report into the Regulatory Affairs Director and have accountability for developing and enhancing the organisations capabilities in the areas of drug development, regulatory compliance and leadership.

KEY DUTIES AND RESPONSIBILITIES:

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

1. Based on understanding regulatory requirements, you will be accountable for driving the generation of appropriate and well controlled technical documents, increasing the chances of first time approval and reducing the need for change applications for markets worldwide (primary focus in EU, UK and US).

2. You will develop and lead small team (4) of technical experts who are responsible for writing CMC regulatory documents ensuring required input from scientific staff, including responses to CMC regulatory questions, CMC scientific advice briefing documents, CMC Module 2 and 3 documents as well as CMC parts of clinical trial applications.

3. Establish in collaboration with the product owners the list of upcoming as well as the supportive documentation required to support the filing of the manufacturing changes. Negotiate and agree with Validation, R&D, Production, Supply Chain, Quality and Engineering the level of data required for submission, and what would rather be nice to have (risk assessment).

4. To drive Regulatory Compliance to a higher standard, the role includes responsibility for checking consistency between data submitted as part of licensing activities and approvals with current manufacturing SOPs.


ROLE REQUIREMENTS:

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

1. Relevant degree qualification in a Life Science or Scientific related discipline, in addition to extensive Regulatory Affairs experience with exposure to all areas of Regulatory Affairs.

2. Proven industry experience of Regulatory Submissions including the preparation and review of submissions, ideally to a range of markets with exposure to a range of submissions systems. Ideally within a biologics manufacturing environment, however, other Life Sciences and Pharmaceutical experience will also be considered.

3. Extensive knowledge of Regulatory CMC for products in development and manufacture with experience of the management of change control processes.


Key Words: CMC | Regulatory Complaince | Regulatory Affairs | Regulatory CMC | Manufacturing | Pharmaceutical | Biopharmaceutical | Biologics | GMP


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 +

Find Us
Website:
Telephone
0203 910 2980
Location
Amshold House
Goldings Hill
Loughton,
Essex
IG102RW
GB
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