Regulatory Sciences Manager, Lifecycle Management

ProPharma; Stockholms kommun; Hybrid; SEK 900,000 - 1,100,000; Full time

Benefits offered by this job

Hybrid work model

Career advancement

Global team

Diversity & inclusion

Job summary

ProPharma Nordic Regulatory Affairs team seeks a Regulatory Affairs Manager to lead projects for pharmaceutical clients across the Nordic region, from biotech to global pharma. You will navigate regulatory submissions, liaise with health authorities, and provide strategic regulatory advice.

The role requires 5+ years in Regulatory Affairs, Nordic regulatory expertise, MSc in Pharmacy, fluent English and a Nordic language, and a collaborative, client-focused mindset.

Qualifications

• 5+ years in Regulatory Affairs with strong Nordic focus.
• Solid understanding of registration procedures and lifecycle management.
• MSc in Pharmacy or equivalent scientific degree.
• Fluent in English and at least one Nordic language.
• Experience with regulatory compliance review of Nordic promotional material.
• Strong client focus and excellent communication skills.

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 pharmaceuticals and medical devices.
• Collaborate with cross-functional teams within ProPharma Group.
• Take initiative in leading projects and coordinating with stakeholders.

Skills

Regulatory affairs

Nordic regulations

Client focus

Interpersonal communication

English proficiency

Nordic language proficiency

Education

MSc in Pharmacy

Job description

For the past 25 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 Regulatory Affairs Manager to join our Nordic Regulatory Affairs team.

Your Role

As a 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 contributing to a positive team dynamic. You thrive on building strong relationships through regular interactions with clients and cross-functional teams. You are proactive, detail-oriented, and comfortable working in dynamic environments where adaptability is key.

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

• At least 5 years 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 English and at least one Nordic language (oral and written); proficiency in additional Nordic languages 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

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

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.