Regulatory Affairs Officer / Regulatory Officer

Job Title: Regulatory Officer - Minimum 12 month rolling contract

Location: Middlesex

The Client: Medium sized pharmaceutical company specializing in the development, licensing and marketing of niche generic medicines and proprietary brands in the UK and across Europe

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

The Role:

Ensuring that the Company's products comply with the Regulations of the MHRA.
Provides regulatory information, guidance and support o the R&D, Commercial, Clinical and Quality functions with respect to the development of the Company's products.
Responsible for the timely management preparation, submission and follow-up of regulatory initial submissions to competent authorities, in whose territories the Business wishes to operate.
Ensuring all preparation, submission and follow-ups of licence variations and approvals are carried out in a timely manner.
Writing clear, accessible product labels and patient information leaflets.
Specifying storage, labelling and packaging requirements.
Planning and managing new product development.
Continuously maintaining the quality systems.
Ensures regulatory procedures and systems are implemented in order to comply with regulatory requirements and agreed quality standards.
Undertaking and managing the Regulatory inspections.
General Administration work related to the Regulatory activities and managing all external and internal communication activities.

The Candidate:

Must hold a qualification in a pharmaceutical science i.e. Life Science.
Must have a minimum of two years experience of working within the Pharmaceutical industry.
Previous experience of assessing and writing CMC dossiers.
Minimum 6 months experience of working on preparation and submission of variations for different type 1A, 1B, and II variations.
Minimum 6 months experience of working on preparation and submission of dossiers (e.g. National, DCP and MRPs).
Able to assess CMC and formulation development documents in line with the EU and ICH guidelines.
Previous experience of assessing and writing CMC dossiers.
Excellent communication skills (oral and written) and interpersonal skills.

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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