For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. As the world’s largest RCO (Research Consulting Organization), ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.
ProPharma Group Sweden is located in central Stockholm with a smaller site in Lund. As a result of the continuous growth of our company, we are now looking to recruit a Senior Regulatory Consultant to our Regulatory Affairs Division. The position can be based either in Stockholm or in Lund.
In the role as Senior Regulatory Consultant, you will be working on projects from a variety of Pharmaceutical companies. On the projects you will be dealing with challenging and varied tasks that requires you to be result and client orientated and to display excellent interpersonal skills. At the same time, you will have the opportunity to actively participate in the company’s continued development.
The work may include, but is not limited to:
- 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 client and colleagues
- Regular follow-ups with clients
- Follow up related to projects and quality
- Collaborate with other line services within the company
Qualifications
- 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
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.
***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***
What We Do
ProPharma is the premier Research Consulting Organization (RCO), delivering fully customizable consulting solutions to empower biotech, med device, and pharmaceutical organizations of all sizes to advance scientific breakthroughs confidently and introduce new therapies.
With over 20 years of expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma partners with clients across the complete product lifecycle through an advise-build-operate model. Our end-to-end suite of consulting solutions de-risk and accelerate high-profile drug and device programs, ultimately improving patient health and safety. Discover how ProPharma can help you inspire the future of science
