Regulatory Strategy Project Lead - New Works, United Kingdom - Hyper Recruitment Solutions Ltd

Hyper Recruitment Solutions Ltd
Hyper Recruitment Solutions Ltd
Verified Company
New Works, United Kingdom

2 weeks ago

Tom O´Connor

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Tom O´Connor

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Description
We are currently looking for a Regulatory Strategy Project Lead to join a leading Therapeutics business producing life-changing products.

As the Regulatory Strategy Project Lead, you will be responsible for developing and leading the global regulatorystrategies, as well as the following:


KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Regulatory Strategy Project Lead will be varied, however the key duties and responsibilities are as follows:

  • Develop and lead the global regulatory strategies, driving these forward along with plans for product development, ensuring the successful delivery of approvals and launches of products.
  • Develop and improve the procedures for the Regulatory Strategy group, improving efficiency and consistency across the business, as well as providing expert guidance and support to R&D teams to enhance the businesses pipeline.
  • Provide expertise on current drug development and marketing authorisation requirements, ensuring efficient procedures are enabled for effective product development, including approval strategies and ensuring they are aligned with R&D and Commercial activities.
  • Ensure you maintain and improve your awareness of current and emerging regulatory & scientific guidance required for the business, providing advice to R&D teams regarding anything that may affect product development plans.

ROLE REQUIREMENTS:

  • Relevant degree within a Scientific discipline.
  • Significant experience within the biotech/pharmaceutical sector within a Regulatory position.
  • A working knowledge and practical experience of Regulatory guidance and legislation across the UK & EU.

Key Words:
Regulatory, R&D, Research and Development, Therapeutics, Strategy,
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