Regulatory Affairs Project Coordinator

Job Title: Regulatory Affairs Project Coordinator

Location: Middlesex

Duration: ASAP - 12 month contract

The Client: Global Pharma Company

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

The Role:

Coordinating tech transfer and new product launches.
Requesting and chasing requested documents from formulators, manufacturers and suppliers.
Ordering of Active pharmaceutical ingredient, impurities, innovator samples and sending to formulators or manufacturers for validation batches.
Organising meetings between various departments and external meetings.
Writing and distributing minutes of meetings and tracking outstanding issues.
Liaising with Contract Manufacturers and Quality Control for completion for allocated projects.
Preparation of documents for Regulatory Variations and Quality modules.
Checking documentation meet NEEs requirement (non-electronic format) for variation and submission.
Proof reading of artworks.
Providing information on trackers to various departments.
Supporting the department for preparation for inspections.
General Administration work related to the Regulatory activities and managing all external and internal communication activities.

The Candidate:

A minimum of 6 months experience of working in coordinating technology transfer of products and project coordination.
Experience of working within a Regulatory department.
Have an understanding of the Quality Assurance and Quality Control department's activities.
Strong IT skills (proficient in MS Office: Word, Excel and Outlook).
Extremely organised to deal with a variety of projects and able to prioritise conflicting demands.
High level of accuracy and good attention to detail.
Ability to work under pressure with multiple projects to strict on-going deadlines.
The ability to grasp new concepts quickly and to assimilate data from a wide range of Scientific areas.
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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