Principal Regulatory Affairs Associate

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

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Job Details

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

We are currently looking for a Regulatory Affairs Principal Associate to join a leading pharmaceutical company based in the West Yorkshire area.

As the Regulatory Affairs Principal Associate you will be responsible for the hands on regulatory activity required to submit, approve and launch new products as well as the maintenance of existing commercialised products.

KEY DUTIES AND RESPONSIBILITIES:

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

1. You will be responsible for the execution of regulatory activities to meet current legislation and local laws as per the project plan to assure new products meet submission, approval and commercial launch goals.

2. You will review and approve documentation prepared by internal & external stakeholders, independently using regulatory knowledge and guidelines to ensure compliance for new marketing authorisations, including marketing materials.

3. As the Regulatory Affairs Principal Associate, you will also ensure regulatory files and data systems are maintained in compliance with SOPs and KPIs in line with business goals as well as ensure compliance with appropriate global legislation governing regulatory, safety, manufacturing and distribution of product resulting in no interruption to flow of business or impact on company reputation.

4. You will be representing and negotiating for regulatory affairs in project meetings with internal & external stakeholders. As a product owner, independently providing comprehensive and detailed regulatory advice to support the business including change control SME.


ROLE REQUIREMENTS:

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

1. Relevant Life Sciences degree and extensive experience working in a regulatory affairs position within a pharmaceutical company is essential for this role as you will need to have a good understanding of regulatory legal basis licensing requirements in particular generic submissions.

2. The Regulatory Affairs Principal Associate will have detailed CMC knowledge and a general understanding of bioequivalence. Any knowledge of formulation development proves advantageous.

3. Starting to develop managerial skills with evidence in problem solving, prioritisation of goals and stating to provide easy strategies for general stage gate products.


Key Words: Regulatory Affairs | Principal | Manager | CMC | Pharmaceutical | Formulation Chemistry | Life 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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