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Regulatory Affairs Associate

Employer
Apex International Recruitment Ltd
Location
Hybrid working - 2 days office (Surrey), 3 days WFH
Salary
Competitive salary and benefits
Start date
27 Nov 2023
Closing date
11 Dec 2023

Job Details

DETAILS:

  • Full-time permanent position
  • Hybrid working - 3 days WFH, 2 days office (Surrey)
  • Competitive package
  • Global pharma company

 

THE ROLE:

Objective / Purpose of Role

To support the Regulatory Affairs function of the Operations department, carrying out a range of tasks supporting the fulfillment of responsibilities of the Marketing Authorisation Holder for the product portfolio, working with Quality Assurance, Medical Affairs, and external contractors.

Key Activities / Key Responsibilities

  • Support the preparation and review of regulatory applications such as variations, change of ownership applications, renewals in the UK, EU and globally Regulatory compliance tracking
  • Regulatory filing and administration
  • Communication of regulatory changes internally and externally
  • Generation, review and implementation of Product Information (Summary of Product Characteristics, leaflets and labelling)
  • Review and processing of certificates of analysis for received product batches
  • Review of stability reports, annual Product Quality Reviews, SOPs, other technical documents and change controls
  • Review and support updates to product Artwork
  • Handling Product Quality Complaints

Full job description available on application

 

THE CANDIDATE:

  • Degree in Pharmacy, Chemistry, Pharmaceutical or life sciences
  • Life Science industry, e.g. regulatory affairs function.
  • Minimum 1 year UK regulatory experience - ideally experience in variations, labelling and artwork changes

* Please note that only candidates currently living in the UK with Right To Work in the UK in place will be considered.

TO APPLY:

Please complete the details below to apply. For further information or a discreet discussion regarding your recruitment requirements, please call Alex on 01227 844466 or email alex@apexrecruitment.com

To view our other vacancies, please visit our website on www.apexrecruitment.com

Apex Recruitment are a specialist agency providing opportunities within the pharmaceutical, biopharma, biotech and medical device industries recruiting in the areas of medical affairs, drug safety, clinical and quality.

Company

Apex International Recruitment are experts in recruiting for the Pharmaceutical and Life Science sectors across the UK.

We work exclusively with some clients, and on PSLs with numerous other agencies operating through RPOs / MSPs with other clients.

Apex are a niche agency providing hiring solutions for both permanent headcount and contractor requirements. We specialise in recruiting for roles across the lifecycle of a product, through from early-stage clinical trials through to manufacturing and from market launch through to established products. We recruit for a number of positions and the sectors we specialise in are listed below:

  • Clinical Research / Clinical Trials
  • Regulatory Affairs
  • Medical Affairs / Medical Information
  • Pharmacovigilance / Drug Safety
  • Quality Control, Quality Assurance and Supply Chain
  • Health Economics / Market Access
  • Clinical Data Management
  • Healthcare Compliance
  • Industrial Pharmacists

We have the ability to recruit for the areas above from entry level through to Senior Director level.

Company info
Website
Telephone
01227 844466
Location
Clover House
John Wilson Business Park
Whitstable
Kent
CT5 3QZ
United Kingdom

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