Regulatory Science Leader

9 hours ago


Stockholm, Stockholm, Sweden TN Sweden Full time

About the Role:

Senior Manager, Regulatory Sciences - Development

Company Overview: ProPharma Group has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations to advance scientific breakthroughs.

Job Description: As a Senior Manager, Regulatory Sciences, you will lead discreet client projects, manage complex tasks, and contribute to overall project strategy. You will interact with clients and regulatory agencies on defined projects, build strong client relationships, and participate in client strategy discussions.

Responsibilities:

  • Lead discreet client projects through all project phases to ensure efficient execution.
  • Author global nonclinical/clinical aspects of regulatory documentation.
  • Project Management of assigned projects according to internal procedures.
  • Provide expert guidance and technical expertise.
  • Manage interactions with clients and regulatory agencies.
  • Build and maintain strong client relationships.
  • Contribute to regulatory/industry workshops, trainings, and calls for collaboration.
  • Mentor and coach junior staff, if necessary.

Requirements:

  • Advanced degree (MSc/PhD) in a relevant field preferred.
  • Bachelor's degree in a life science field or a related discipline necessary.
  • 8-10+ years' experience within regulatory sciences for development products preferred.
  • Expertise with nonclinical/clinical regulatory writing and knowledge of nonclinical/clinical strategies for development products.
  • Experience managing client relationships within a consultancy setting.
  • Demonstrated leadership and client-facing skills.


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