Regulatory Quality Compliance Executive

Job Title: Regulatory Quality Compliance Executive

Location: London

The Client: Medium sized pharma company with extensive portfolio based in central London looking for an experienced Regulatory Quality Compliance Executive for a minimum 12 month contract

Benefits: Competitive Salary and benefits available - Full details available on application

The Role:

MAIN PURPOSE OF ROLE:

The Quality Management & Compliance (QMC) Team within the Medical & Regulatory Department is responsible for ensuring Marketing Authorisations (MA's) are compliant and being followed by Third Party Manufacturers.
A product compliance project is on-going to review the companies 1600 MA's.

KEY RESPONSIBILITIES AND ACCOUNTABILITIES:

Be part of the team working on the Client product compliance project.
Perform detailed regulatory gap analyses and identify discrepancies between registered information and the processes and documentation used during manufacture including compliance review of APIs and key excipients.
Liaise with third party manufacturers and Regulatory Affiliates to obtain required information.
Review the identified discrepancies, propose appropriate remedial activities and liaise with the team and project lead to agree required actions
Execute and follow up on the agreed actions including compilation of supporting data, raising change controls and assisting in the preparation of variations (UK, EU and ROW) where appropriate.
Maintain accurate and compliant records of gap analysis and remediation activities
Work within the agreed processes, SOPs and timeframes set for the project as a whole and on an individual basis.
Achieve and maintain excellent cross functional working
Collaborate across the unit when required to achieve operational effectiveness

Full details available on application

The Candidate:

Regulatory affairs / Regulatory Compliance experience
Quality Assurance / Compliance experience
Experience within the Pharmaceutical sector
Experience in performing Regulatory Gap analysis
Good working knowledge and understanding of eCTD format
Knowledge of legacy formats eg, NTA, Part II

Application Details:

If your skillset is relevant for this role, please click to apply on the link below. However, if this role doesn't suit your current skill-set, please call Alex on for further advice.

Candidates must provide confirmation that they have valid and existing permission to live and work in the UK.

If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment process.

About Apex: Apex International are an honest, knowledgeable and niche agency who recruit for the pharmaceutical, biotech and CRO sectors in the UK and EU. We specialise in the areas of: Medical Information, Medical Affairs, Pharmacovigilance, Drug Safety, Regulatory Affairs, Clinical Research, QA & QC, Clinical Data Management, Health Economics, Marketing and Pharmacy (Pharmacists, Pharmacy Technicians and Dispensers). For a confidential and professional chat about your job requirements with an agency who are expert in the fields they recruit for, and for the chance to register for free and receive weekly job updates, please call on or email

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