Senior Regulatory CMC Manager

Employer
Hyper Recruitment Solutions
Location
Oxfordshire
Salary
Not specified
Closing date
17 Dec 2022

View more

Sector
Regulatory Affairs
Contract Type
Permanent
Hours
Full Time
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Job Details

A fantastic opportunity has become available for a Senior Regulatory CMC Manager to join a fast-growing Biotech company based in the Oxford area. As the Senior Regulatory CMC Manager you will be responsible for the development of the CMC Strategy for all projects within the organisation.

This is a hybrid position, working 2-3 days on-site per week.


KEY DUTIES AND RESPONSIBILITIES:

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

1. The preparation of CMC submissions for investigational products to key regulatory agencies such as the FDA and EMA. You will also be responsible for oversight of CMC document preparation and timelines when subcontracted to a Contract Service Provider.

2. Provide direct liaison with Regulatory Authorities on relevant CMC issues, and the development of any necessary contingencies for CMC submissions in collaboration with internal and external contributors.

3. You will ensure that CMC submissions are of high quality, meet all regulatory requirements and are compliant with corporate goals and directives, providing regulatory feedback to the project teams and senior management.

4. While supporting regulatory inspections, you will establish and update required regulatory quality systems and required Standard Operating Procedures to guarantee the relevant oversight of all internal and external communications.. This role will also work closely with the Clinical Operations Department.


ROLE REQUIREMENTS:

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

1. The successful candidate will be educated to degree level, within a relevant scientific discipline or similar.

2. You will have a wealth of experience within CMC Regulatory Affairs from the Biopharmaceutical industry

3. A working knowledge of Biologics products, their implementation into the market whilst adhering to licensing procedures, with a focus on centralised practices.


Key Words: CMC | Regulatory Affairs | RA | Biotech | Biopharmaceutical | Biologics | CMC submissions


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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