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Manager of Regulatory Affairs

West YorkshirePermanent
Experience Dependent
Job Reference: J5635695
Updated On: 03/12/2021
Status: Open to Applications
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 - OTC, Regulatory Affairs - REACH, Regulatory Affairs - IMP, Regulatory Affairs - Drug Safety, Regulatory Affairs - Generics, Regulatory Affairs - Biologics, Regulatory Affairs - ATMPs, Dosage Forms - Liquids, Dosage Forms - Steriles / Injectables, Dosage Forms - Suspension / Solutions, HRS - Working From Home

Job Information

Role Overview

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 companys 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.
Debra Fong
Your Recruitment ConsultantDebra
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.