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Regulatory Affairs Principal Associate

West YorkshirePermanent
Experience Dependent
Job Reference: J5633944
Updated On: 23/05/2022
Status: Under Offer
Hyper Recruitment Solutions
Sectors: Pharmaceutical, Contract Manufacturing Organisation, Life Sciences

Skills: Regulatory Affairs - Permanent, Regulatory Affairs - EU, Regulatory Affairs - UK, Regulatory Affairs - Global, Regulatory Affairs - CMC, Regulatory Affairs - REACH, Regulatory Affairs - IMP, Regulatory Affairs - Drug Safety, Regulatory Affairs - Biologics, Regulatory Affairs - ATMPs, HRS - Working From Home

Job Information

Role Overview

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

We are currently looking for a Regulatory Affairs Principal Associate to join a growing pharmaceutical company based in the Leeds 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 and will work with your line manager to develop strategies to support new product development.

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. Independently 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 as per the relevant competent authorities requirements and in compliance to local laws and regulations.

2. You will be responsible for leading and negotiating for regulatory affairs in meetings with internal & external stakeholders, working cross functionally to achieve the business goal. As a product owner, independently providing comprehensive and detailed regulatory advice to support the business including change control SME.

3. As the regulatory affairs principal associate, you will also review and approve variations strategies and documentation prepared by other members of the regulatory team whilst supporting and training associate team members in the regulatory affairs team.

4. You are responsible for ensuring regulatory files and data systems are maintained in compliance with SOPs and KPIs in line with business goals and also support continuous improvements to regulatory and business processes.

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

2. Track record and proven pharmaceutical industry experience in a senior regulatory affairs position is essential for this role.

3. Experience in a regulatory affairs role working with liquid dose form products is highly desirable.
Ben Hamlin
Your Recruitment ConsultantBen
DisclaimerHyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for our talent development. We welcome applications for any applicant 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 processionals and scientists. We look forward to helping you with your next career moves.