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Regulatory Affairs Associate Director

London

Negotiable

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 global regulatory affairs strategist, you will be responsible for the development of regulatory strategies for specific international regions focusing on new therapeutic indications and regulatory involvement on an innovative R&D pipeline as it moves through the cycle.

With strong communication and relationship building skills, you will represent our client internally and externally on 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.

Key Responsibilities

  • Manage international regulatory strategies and liaise with regulatory authorities across key products/regions
  • Oversee regulatory submissions such as CTA, MAA and PIP according to regional requirements
  • Manage regulatory project timelines and prioritisation
  • Act as Regulatory Affairs subject matter expert engaging with senior leadership on regulatory projects as well as policy advice

Requirements

  • Significant experience in a regulatory role within the pharmaceutical industry focusing on the development of regulatory strategy and submissions
  • UK, European and International regulatory affairs expert
  • A life science degree is essential (Masters or PhD preferred but not essential)
  • Strong clinical development background
  • 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

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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