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. 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.
About Us
At ProPharma, we help pharmaceutical, biotechnology, and medical device companies bring life-changing therapies to market. From early development through clinical, regulatory approval, and commercialization, we provide expert guidance to navigate complex challenges and accelerate success.
Our mission is simple - improving patient health and safety by delivering the highest quality regulatory, compliance, clinical research, pharmacovigilance, and medical information services throughout the entire product lifecycle.
Our Swedish operations are based in central Stockholm, with a satellite office in Lund. We are now seeking a Senior Regulatory Affairs Manager to join our Nordic Regulatory Affairs team.
Your Role
As a Senior Regulatory Affairs Manager, you will lead and contribute to diverse projects for a range of pharmaceutical clients, from emerging biotech firms to global pharma leaders. You will be dealing with challenging and varied tasks that require you to be result and client orientated and to display excellent interpersonal skills.
Your Profile
We are looking for a collaborative team player who enjoys sharing knowledge, supporting colleagues, and is eager to grow together. You naturally take on informal leadership roles and thrive in building strong, lasting relationships through regular interactions with clients and cross-functional teams. You are proactive, detail-oriented, and energized by dynamic environments.
Key Responsibilities:
- Provide expert regulatory support across the Nordic region (Sweden, Denmark, Norway, Finland, Iceland)
- Manage submissions including new registrations, variations, and MAH transfers
- Liaise with health authorities and stay current with regulatory intelligence
- Offer strategic and operational regulatory advice to clients and internal teams
- Product launches and lifecycle management with a Nordic focus
- Ensure quality and compliance through regular project follow-ups
- Review of promotional material for both pharmaceuticals and medical devices
- Collaborating with cross-functional teams within ProPharma Group
- Take initiative in leading projects and coordinating with stakeholders
Qualifications:
- Minimum 7 years of experience in Regulatory Affairs, with a strong focus on Nordic regulations. Having worked with Regulatory Affairs at headquarter level is a plus.
- Solid understanding of registration procedures and product lifecycle management
- MSc in Pharmacy or equivalent scientific degree
- Fluent in Swedish and English (oral and written); proficiency in another Nordic language is a plus
- Experience from regulatory compliance review of promotional material for the Nordics
- Strong client focus and ability to adapt to varying needs
- Excellent interpersonal and communication skills and enjoys regular interaction with clients and internal stakeholders
- Comfortable taking on informal leadership roles and coordinating project teams
What We Offer
At ProPharma Group, you will be part of a global team that values expertise, innovation, and personal growth.
- Work on challenging and diverse regulatory projects
- Influence ways of working and regulatory strategies for a wide range of clients
- Working on varied tasks provides the opportunity to keep up to date with regulatory intelligence
- Collaborating with talented colleagues across departments and geographies'
- Work in a hybrid model, offering the flexibility to combine remote work with in-office collaboration.
- Be part of a growing international company with opportunities for career advancement
Ready to make an impact?
Join us and help shape the future of regulatory affairs in the Nordics.
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.***
