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Regulatory Affairs Senior Associate

Employer
Hyper Recruitment Solutions
Location
Leeds
Salary
Dependent on experience
Closing date
12 Jun 2022

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Sector
Regulatory Affairs
Contract Type
Permanent
Hours
Full Time
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Job Details


Are you an experienced regulatory affairs associate looking for a new exciting job opportunity?

We are currently looking for a Regulatory Affairs Senior Associate to join a growing pharmaceutical company based in the Leeds area.

As the Regulatory Affairs Senior Associate you will be responsible for the hands on regulatory activity required to submit, approve and launch new products with minimal and / or no supervision.

KEY DUTIES AND RESPONSIBILITIES:

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

1. You will assist in the execution of regulatory activities per the project plan to assure new products meet submission, approval and commercial launch goals. Including management of applications for new marketing authorisations (with minimal supervision) as per the relevant competent authorities requirements and in compliance to local laws and regulations.

2. You will be responsible for reviewing and approving variations strategies and documentation prepared by other members of the regulatory team as well as identify risks to the submission, engaging in proactive discussion with line manager, health authorities or other stakeholders to resolve any regulatory issues related to new marketing authorisations.

3. Additionally, as the regulatory affairs senior associate, you will also be an active participation as regulatory affairs representative in meetings with internal & external stakeholders, working cross functionally to achieve the business goal. As a product owner, providing comprehensive and detailed regulatory adviceto support the business including change control SME.

4. You will also be responsible for developing and approving product information text in compliance with SOPs and relevant pharmaceutical guidelines for the new marketing authorisation.

ROLE REQUIREMENTS:

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

1. A relevant Life Science / Pharmaceutical degree is required for this position.

2. Proven work experience in a senior regulatory affairs within the pharmaceutical industry is essential for this position as you will be expected to work with minimal / no supervision.

3. Industrial regulatory affairs experience for liquid dosage forms would be highly desirable and advantageous.


Key Words: Regulatory Affairs | Pharmaceutical | Life Science | Drug Formulation | Chemistry

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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