Senior Manager, Regulatory Affairs Lead

11 hours ago


Stockholm, Stockholm, Sweden TN Sweden Full time

About the Role

Senior Manager, Regulatory Sciences

ProPharma Group is a global leader in regulatory sciences, providing expert advice and solutions to biotech, med device, and pharmaceutical organizations.

Key Responsibilities

  1. Lead client projects, ensuring efficient project execution and contributing to larger projects.
  2. Author global nonclinical/clinical aspects of regulatory documentation, including environmental risk assessments and marketing authorisation applications.
  3. Project manage assigned projects, monitor budgets, and provide expert guidance and technical expertise.
  4. Build strong client relationships, manage expectations, and participate in client strategy discussions.
  5. Stay informed of relevant regulatory developments and contribute to workshops, trainings, and calls for collaboration.

Requirements

  1. Advanced degree (MSc/PhD) in a relevant field preferred.
  2. Bachelor's degree in a life science field or related discipline necessary.
  3. 8-10+ years' experience within regulatory sciences for development products preferred.
  4. Expertise with nonclinical/clinical regulatory writing and advanced knowledge of nonclinical/clinical strategies.
  5. Experience leading and delivering successful projects within budget and timeframe.
  6. Demonstrated leadership and client-facing skills.


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