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UK Regulatory Affairs Associate Director

MarkerLondon CoinNegotiable

Vacancy summary

Reference: 08988

Job Type: Permanent

Date Posted: 16 March 2021

  • Strategic senior regulatory affairs role for UK
  • Working in conjunction with global stakeholders
  • Dynamic and positive company growing consistently year-on-year

A global biotechnology company at the forefront of innovative medicine, they are looking for an Associate Director -  Regulatory Affairs to join their team.

As a UK regulatory affairs specialist, you will take ownership of the relationship with MHRA, you will be part of the strategy team looking to develop UK regulatory in the post Brexit marketplace. 

Strong communication and relationship building skills will enable to represent our client internally and externally on UK regulatory affairs matters.  A combination of strategy and delivery, this is a role where you can take ownership whilst working in a matrix/collaborative environment.

This is a great opportunity to work for a pharmaceutical company who have created a centre of excellence and constantly focus on driving innovation and using cutting edge techniques in their science.

Key Responsibilities

  • Manage the UK portfolio and oversee regulatory procedures such as CTA, MAA, PIP and orphan submissions
  • Being the Regulatory Affairs Subject Matter Expert whilst ensuring national requirements are followed
  • Act as main contact with the MHRA

Requirements

  • Significant experience in a regulatory role within the pharmaceutical industry
  • UK regulatory affairs expert
  • A life science degree is essential (Masters or PhD preferred but not essential)
  • Previous experience leading regulatory authority engagement and negotiations
  • Exposure developing and implementing regulatory affairs strategies
  • Great knowledge of drug lifecycle development and post authorisation procedures
  • Strong communication and leadership skills
  • Able to commit to 3-4 days in the office once COVID-19 restrictions are lifted

Park Street People is an Equal Opportunities Employer. We do not discriminate on the grounds of age, race, gender, disability, creed or sexual orientation and comply with all relevant UK legislation. We are acting an Employment Agency in relation to this role.

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