Regulatory Strategy Project Lead

1 month ago


New Works, United Kingdom Hyper Recruitment Solutions Ltd Full time

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:
1.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.
2.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.
3.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.
4.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:
1. Relevant degree within a Scientific discipline.
2. Significant experience within the biotech/pharmaceutical sector within a Regulatory position.
3. 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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