Senior Regulatory Consultant

2 months ago


Stockholm, Stockholm, Sweden ProPharma Group Full time

About the Role

ProPharma Group is seeking a highly skilled Senior Regulatory Consultant to join our Regulatory Affairs Division. As a Senior Regulatory Consultant, you will be working on projects from a variety of Pharmaceutical companies, dealing with challenging and varied tasks that require you to be result and client-oriented and to display excellent interpersonal skills.

Key Responsibilities

  • Working with Regulatory Affairs, primarily on a local level, with focus on the Nordic countries (Sweden, Denmark, Norway, Finland, and Iceland)
  • New registrations/variations/MAH-transfer applications
  • Regular contact with health authorities
  • Regulatory intelligence
  • Local regulatory advice
  • Launch preparations
  • Strategic and operational regulatory support to clients and colleagues
  • Regular follow-ups with clients
  • Follow-up related to projects and quality
  • Collaborate with other line services within the company

Requirements

  • Understanding of registration procedures and requirements as well as product life cycle management from regulatory affairs perspective
  • Having an open eye for the needs of your customers and the ability to adjust to these needs
  • Able to work to deadlines and solving issues in a pragmatic and proactive way
  • Ensuring you are able and willing to dig into the details yet keeping an eye on the overall goal of the project
  • Excellent communication skills (oral and written) in Swedish & English language. Another Nordic language is a benefit but not a must
  • 5+ years of experience in Regulatory Affairs, primarily focused on Nordic regulations
  • MSc in Pharmacy, or equivalent

About ProPharma Group

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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