Senior Regulatory Affairs Specialist, Development

12 hours ago


Stockholm, Stockholm, Sweden TN Sweden Full time

Role Overview

As a Senior Manager, Regulatory Sciences, you will lead client projects, ensuring efficient project execution and contributing to larger projects.

Key Responsibilities

  1. Author global nonclinical/clinical aspects of regulatory documentation, including environmental risk assessments and marketing authorisation applications.
  2. Project manage assigned projects, including approval of time entry and invoicing, budget monitoring, and client liaison.
  3. Provide expert guidance and technical expertise, manage complex tasks, and contribute to overall project strategy.
  4. Build strong client relationships, manage expectations, and participate in client strategy discussions.

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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