Regulatory Sciences Manager

1 day ago

London, Greater London, United Kingdom ProPharma Group Full time
Senior Manager, Regulatory Sciences

ProPharma Group is seeking a highly experienced Senior Manager, Regulatory Sciences to join our team. As a key member of our regulatory team, you will be responsible for leading client projects and project teams through all project phases, ensuring efficient project execution and contributing to larger projects.

Responsibilities:
  • Lead client projects and project teams through all project phases, ensuring efficient project execution and contributing to larger projects.
  • Author global nonclinical/clinical aspects of regulatory documentation, including environmental risk assessments, development plans, briefing books, orphan designations, paediatric investigation plans, marketing authorisation applications, and contributing to gap analyses and regulatory strategies.
  • Project Management of assigned projects in accordance with internal procedures, including approval of time entry and invoicing, budget monitoring, client liaison, and service growth.
  • Provide expert guidance and technical expertise, manage complex tasks, and contribute to overall project strategy.
  • Lead interactions with clients and regulatory agencies on defined projects.
  • Build strong client relationships, manage client expectations, and participate in client strategy discussions.
  • Support development of client budgets and business proposals.
  • Stay informed of relevant regulatory developments and contribute to regulatory/industry workshops, trainings, and calls for collaboration.
  • Contribute to the ongoing improvement of internal regulatory processes and procedures.
  • Mentor and coach junior staff, line management if necessary.
Requirements:
  • Advanced degree (MSc/PhD) in a relevant field preferred.
  • Bachelor's degree in a life science field (e.g., biology, pharmacy, pharmacology, toxicology) or a related discipline necessary.
  • 8-10+ years' experience within regulatory sciences for development products preferred.
  • Expertise with nonclinical/clinical regulatory writing and advanced knowledge of nonclinical/clinical strategies for development products.
  • Experience of leading and delivering successful projects within budget and timeframe.
  • Experience managing client relationships within a consultancy setting preferred.
  • Demonstrated leadership and client-facing skills.

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.

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