Senior Manager Regulatory Sciences Expert

3 weeks ago


Stockholm, Stockholm, Sweden ProPharma Group Full time

At ProPharma Group, we are seeking a highly skilled Senior Manager Regulatory Sciences to lead our client projects and teams through all project phases. As a key member of our team, you will be responsible for independently leading discreet client projects, managing complex tasks, and contributing to overall project strategy.



Responsibilities


  • Project Management: Manage assigned projects in accordance with internal procedures, including approval of time entry and invoicing, budget monitoring, client liaison, and service growth.
  • Regulatory Writing: Author global nonclinical/clinical aspects of regulatory documentation, including environmental risk assessments, development plans, briefing books, orphan designations, paediatric investigation plans, and marketing authorisation applications.
  • Client Liaison: Lead interactions with clients and regulatory agencies on defined projects, build strong client relationships, manage client expectations, and participate in client strategy discussions.
  • Team Leadership: Mentor and coach junior staff, provide expert guidance and technical expertise, and contribute to the ongoing improvement of internal regulatory processes and procedures.


Requirements


  • Education: Advanced degree (MSc/PhD) in a relevant field preferred, or Bachelor's degree in a life science field (e.g., biology, pharmacy, pharmacology, toxicology) or a related discipline necessary.
  • Experience: 8-10+ years' experience within regulatory sciences for development products preferred, with expertise in nonclinical/clinical regulatory writing and advanced knowledge of nonclinical/clinical strategies for development products.
  • Skills: Proven leadership and client-facing skills, with experience managing client relationships within a consultancy setting preferred.


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, and we provide a safe space where all employees feel empowered to succeed.



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