Regulatory Affairs Manager - Central London - Varied and Broad based role!

Reference: TM10494

Expiry Date: 29-09-2020

Category Regulatory Affairs

Salary: On Application

Job Type: Full Time

Location:
London
Greater London
United Kingdom

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Job Description

Regulatory Affairs Manager - Central London - Varied and Broad based role!

Location: Central London, easily commutable from Liverpool Streel, Kings Cross, Victoria, London Bridge, Paddington and Waterloo.

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 considered as a growing, dynamic 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 Regulatory Affairs Manager you will be responsible for complex scientific post approval projects, working to manage EMA queries and answer questions. With the Regulatory Strategy Lead you will work cross functionally with colleagues in EU, US and Japan to inform and influence. You will support post-marketing licensing requirements and ensure effective liaison across the organisation to optimise regulatory strategies.

In the short-term you will be working in a broad based role in post-marketing regulatory affairs, for 2 recently approved products but in the longer term as you gain more achievements you will have the opportunity to be involved in new development projects as they come through the pipeline.

You will find many great things about this role, it covers most aspects of post-marketing regulatory affairs, including variations and life cycle management through European procedures and you will be working on global teams that includes the EU, US and Japan.  You will also receive development opportunities to move into pre-approval projects and/or supporting new MAA’s. So you will have the opportunity to be involved in new development projects as they come through.

The salary for this role is considered as strong 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.

For this position you will need to have excellent EU post approval experience, this will include:

  • Experience of post-marketing regulatory affairs, including variations and life cycle management through European procedures (CP, DCP, MRP)
  • Ability to work well within a matrix environment, build team relationships and interface in a global team environment at all levels of management
  • 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.

Note: My client has committed to do digital hiring using Skype (VC), and has 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 on +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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