Manager of Regulatory Affairs

Employer
Hyper Recruitment Solutions
Location
West Yorkshire
Salary
Dependent on experience
Closing date
15 Dec 2021

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Job Details


Are you an experienced Regulatory Affairs Manager looking for an exciting new job opportunity?

We are currently looking for a Manager of Regulatory Affairs with experience in Life Cycle Management to join a leading pharmaceutical company based in the West Yorkshire area.

As the Manager of Regulatory Affairs you will be responsible for managing all of the regulatory affairs activities within the company, with a specific focus on life cycle and portfolio management as well as ensuring regulatory compliance in all business transactions.

KEY DUTIES AND RESPONSIBILITIES:

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

1. You will be responsible for ensuring the company's life cycle management regulatory affairs activities are conducted according to relevant regulations, laws, and standards whilst overseeing the company's regulatory application process to obtain all necessary updates to permits, licences, certificates and authorisations.

2. You will be responsible for liaising with regulatory authorities as well as with functional managers internally to understand their business needs (e.g. formalising necessary changes to dossiers and tech transfers).

3. As the Regulatory Manager, you will also over see all regulatory actions for CAPAs, AERs and change controls.

4. You will also be managing, coaching and training a small team of regulatory affairs professionals.

ROLE REQUIREMENTS:

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

1. Relevant Life Sciences degree and extensive experience in the field of Regulatory Affairs. As the Manager of RA, you will also need to have had experience in a supervisory or management role.

2. Detailed CMC knowledge, lifecycle management and a good understanding of variations in the UK & EU are essential for this position. Knowledge globally and eCTD experience would be beneficial.

3. Additionally, current awareness of legal framework and forthcoming legislation that may affect the business is crucial as well as a good understanding of the workings of global competent authorities.

Key Words: Regulatory Affairs | Manager | Principal Associate | Pharmaceuticals | Life Science | CMC | Healthcare | Science

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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