Join our team as a Regulatory Affairs Manager and drive innovation in healthcare at Planet Pharma.
Job Description
We are seeking a dynamic professional dedicated to shaping the future of medicine. In this role you will support the development, approval, and maintenance of groundbreaking medicinal products, ensuring life‑changing therapies reach patients worldwide.
What you will do
* Manage and oversee regulatory submissions, including clinical trial and marketing applications, ensuring compliance with global and local regulatory requirements.
* Develop and implement regional regulatory strategies to accelerate product development and approval processes.
* Provide expert guidance on regulatory documents, meetings, and negotiations to optimize product registrations.
* Stay abreast of evolving legislation, policies, and technical guidance, communicating their impact on regional product portfolios.
* Support label negotiations and regulatory planning activities, influencing decisions that impact product lifecycle management.
* Contribute to the development of regional regulatory strategies and risk assessments, supporting products from early development through post‑marketing.
Required Skills
* University degree in a scientific discipline with demonstrated experience in regulatory affairs.
* Strong knowledge of regulatory principles, policies and procedures related to medicinal products.
* Familiarity with legislation, registration procedures and compliance within regional and global contexts.
* Excellent communication skills—both written and oral—with the ability to clearly convey complex scientific and regulatory information.
* Ability to proactively identify potential issues and develop strategic solutions.
* Proven experience in navigating regional regulatory environments and collaborating effectively with cross‑functional teams.
Nice‑to‑have Skills
* Experience working within the biotech or pharmaceutical industry.
* Knowledge of drug development processes and lifecycle management.
* Familiarity with specialized regulatory pathways such as Orphan Drug, Fast Track or Paediatric plans.
* Experience in label negotiation activities and regional regulatory mechanisms.
Preferred Education and Experience
* Bachelor's degree or higher in a scientific discipline such as pharmacy, biology, chemistry or related field.
* Several years of experience in regulatory affairs, preferably within European or international markets, supporting both clinical and marketed products.
Other Requirements
* Willingness to travel occasionally for onsite meetings (approximately 1 day per month in Uxbridge or Cambridge).
* Ability to work remotely with flexibility for in‑office collaboration.
* Strong organizational skills, attention to detail and ability to manage multiple priorities.
Ready to make a difference in the lives of millions? If you are a proactive, strategic thinker with a passion for regulatory excellence, we encourage you to apply today and be part of a team that is transforming healthcare.
The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
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