Senior Regulatory Consultant
2 months ago
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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