EU Regulatory Affairs Associate Manager - Central London - Full project lifecycle role!

Reference: TM10494BB

Expiry Date: 31-12-2020

Category Regulatory Affairs

Salary: On Application

Job Type: Full Time

Location:
London
Greater London
United Kingdom

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Job Description

EU Regulatory Affairs Associate Manager - Central London - Full project lifecycle role!

Regulatory Affairs Associate Manager - Central London - broad based role covering CTA’s, MAA’s, regulatory strategy, and working on new development projects as they come through the pipeline.

You will find many great things about this role, the team, the culture, the projects and the opportunity for personal and professional growth - this is an environment and company where you are expected to develop and grow your expertise, become more senior, and take on more responsibility!

The salary for this role is very good and the benefits package is comprehensive and includes full medical and healthcare, high level pension contribution from the employer, dental, a great holiday allowance, flexible working hours and options to work from home (currently this role is 100% home based until post COVID).

My client is a small, but expanding global pharmaceutical company with a number of successful recently approved products. They develop products in over 8 different therapy areas and are a company where everyone is expected to make a real difference. They have a friendly culture and offer real career pathways for those that want to expand their horizons.

As a Regulatory Affairs Associate Manager you will support complex scientific developments and post approval projects, working to manage EMA queries and answer questions. With the Regulatory Strategy Lead you will support both development and commercial  project requirements, ensuring effective liaison across the organisation to optimise EU regulatory strategies. In the longer term you will grow and develop your experience and expertise by working on projects where you will be leading PIP’s, ODD’s and CTA’s, and then supporting Scientific Advice meetings & major MAA’s.

For this position you will need to have experience of either:

  • CTA’s and/or working on projects in development

OR

  • post-marketing regulatory affairs, including variations and life cycle management through European procedures (CP, DCP, MRP)

It’s essential to have the ability to work well within a matrix environment, build team relationships and interface in a global team environment at all levels of management. You will need to have the proven ability to plan, effectively coordinate and lead activities simultaneously on multiple projects, many with tight time deadlines. Ideally some experience in EU regulatory submissions, with specific experience of clinical and non-clinical submissions to Health Authorities.

Location: Currently 100% home working, but with a Central London based office, easily commutable from Liverpool Streel, Kings Cross, Victoria, London Bridge, Paddington and Waterloo.

This company are committed to digital hiring using Skype (VC), and have a new digital on-boarding and induction training process in place to allow a smooth transition during SARS-COV-2 outbreak. During the next period, new hires will be allowed to work from home full-time, until such a time occurs when normal working returns.

To Apply!

To apply for this role, please press the red “Apply for position” button, or contact Oli Dimitrov  +44 (0)207 801 3388 or Theo Moore on +44 (0)207 801 3384 in full confidence to receive more details on this role or to hear about other available opportunities in Regulatory Affairs.

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