Planet Pharma
Senior Manager Regulatory Affairs
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Senior Manager, Regulatory Affairs
Join a pioneering leader in the biopharmaceutical industry as a Senior Manager of Regulatory Affairs, where your expertise will directly impact the development and delivery of innovative medicinal products worldwide. In this strategic role, you will lead regional regulatory strategies, oversee critical agency interactions, and ensure compliance across multiple product portfolios. Your contributions will be vital to maintaining timely approvals, supporting clinical trials, and shaping the future of healthcare solutions.
What You’ll Bring
- Extensive knowledge of regional legislation, regulations, and policies related to medicinal products
- Proven experience in developing and executing regulatory strategies for clinical trial and marketing applications
- Strong track record of managing regulatory submissions and negotiations with health authorities
- Exceptional leadership skills with the ability to guide and collaborate across cross-functional teams
- Excellent communication capabilities, adept at translating complex regulatory information into actionable insights
- Analytical mindset with the ability to assess regulatory risks and develop contingency plans
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Nice To Have Skills
- Experience managing or supervising regional regulatory teams or support staff
- Familiarity with expedited pathways such as orphan drug, accelerated approval, and compassionate use programs
- Knowledge of industry best practices in labelling, regulatory documentation, and agency negotiations
- Multilingual proficiency and cultural sensitivity for international collaboration
Preferred Education And Experience
- Bachelor’s degree in Life Sciences, Pharmacy, or a related field; advanced degrees (e.g., Master’s or PhD) are advantageous
- A minimum of 8+ years of regulatory affairs experience within the biopharmaceutical or healthcare industry
- Prior involvement in product development phases from clinical trials through to commercialisation
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Other Requirements
- Ability to work primarily remotely with occasional on-site presence in Uxbridge (approximately one day per month)
- Flexibility to support a 12-month contract with an immediate start preferred
- Willingness to stay abreast of evolving global and regional regulatory landscapes and contribute to strategic initiatives
If you are a strategic thinker with a passion for advancing healthcare through effective regulatory leadership, we invite you to bring your expertise to this dynamic role. Take this opportunity to make a meaningful impact—apply now and help shape the future of life-changing medicines.
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