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Regulatory Affairs Project Manager – Clinical Development

Office based (no home working)

I am working with a leading CRO in Berkshire who is seeking a Regulatory Project Manager to join their team within the EU remit. This company is smaller in size and has a nice family feel as well as a good work/life balance. They invest in their own staff and allow them to develop, as well as being able to accommodate exposure to other teams and potential funding for higher education outside the work place. They work across multiple therapy areas including rare diseases. The office is situated locally to the train station and has free car park on site.


-Participates in all departmental project related activities.
-Prepares clinical trial applications in line with regulatory requirements.
-Reviews and QC’s regulatory documents as required.
-Acts as the regulatory lead for designated projects managing all regulatory aspects.
-Assists the Associate Director RA and RA Managers to manage projects in line with budgets and agreed timelines to achieve client satisfaction.
-Assists RA management in ensuring departmental awareness and compliance of current local, regional, national and harmonised guidance and requirements for the format, content, and control of all types of regulatory and ethics procedures and submissions.
-In conjunction with RA Management, creates and maintains regulatory templates for all types of submissions.
-In conjunction with RA Management, creates and maintains specific project tracking systems incorporating all relevant information.

Candidate Requirements:
-Educated to degree-level in a scientific discipline
-At least 3 years experience in a similar role
-Possesses a thorough understanding of ICH-GCP and maintains professional integrity and respect in this regard.
-Possesses a sound knowledge of global regulatory guidelines covering clinical trials with particular focus on Europe incl. EU clinical trials directive and its practical implementation in individual EU member states.
-Demonstrates ability to understand and follow all relevant SOPs.
-Understands clinical trials methodology.
-Demonstrates a working knowledge of protocols and indications being studied.
-Demonstrates a good understanding of potential project related problems and resolution options.
-Demonstrates ability to collect, interpret and use regulatory data.
-Understands the role of RA within the product life cycle from conception to approval.
-Possesses a basic understanding of clinical trial budgets.
-Demonstrates high self-motivation, and is able to work and plan independently as well as in a team environment.

Regulatory Professionals are more than just a recruitment agency; we are recognised as the most knowledgeable team in the industry and offer a bespoke service, dependent on your specific needs as a candidate. We are ethical as well as dynamic, honest and passionate about what we do.

Alternatively, if this role is not entirely suitable for you or you would like to discuss the role further please contact one of our expert regulatory affairs consultants

You have to be eligible to work in the UK (Tier 1 Visa or EU passport holder)

We also have an excellent referral scheme here at Regulatory Professionals. If you refer someone who we then go on to place, you would be eligible for £250 worth of shopping vouchers!

The Clinical Professionals Group.

Keywords: regulatory affairs reg affairs regulatory senior associate senior executive project manager clinical development CTAs clinical trial applications Europe EU ICH Berkshire Middlesex  West London North London Central London Buckinghamshire Surrey Hertfordshire  officer associate CTA clinical trial applications CRO clinical research organisation permanent pharmaceutical

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