Department Manager, Global Regulatory Affairs

Department Manager, Global Regulatory Affairs

based in Lund, Sweden

About Probi: 

At Probi, we're not just another company - we're pioneers in probiotics, dedicated to enhancing health through scientifically backed products. We are a purpose-driven company, led by science with a mission to enable people to live better lives for longer.

With over three decades of experience, we've earned a global reputation as a scientific frontrunner, holding over 400 patents worldwide and providing probiotic expertise across consumer healthcare and food industries. Our commitment to innovation has propelled us to become a multinational company with centers of excellence spanning three continents.

Job Purpose

The Department Manager of Global Regulatory Affairs oversees Probi's regulatory activities, ensuring product development and manufacturing compliance with health authority guidelines and regulations. This role is responsible for planning, directing, coordinating, and controlling regulatory affairs activities globally, setting strategic and tactical directions for the company within these activities. The role leads a global team of regulatory professionals and reports to the VP, R&D.

Key responsibilities:

People Leadership:

·       Lead and develop the global Regulatory department to foster a high-performing team with a shared vision.

·       Cultivate a collaborative environment built on trust, curiosity, and commitment.

Talent Management:

·       Promote growth and development of team members, and maintain high levels of creativity and credibility.

·       Set clear performance metrics, provide feedback, and recruit and retain top talent to meet future business needs.

Regulatory leadership:

·       Ensure regulatory guidance throughout product life cycle, from early assessment through post launch activities. 

·       Oversee the preparation of global regulatory dossiers, product documentation, registrations, and technical documents. Negotiate with regulatory authorities to ensure submission approval.

·       Monitor relevant regulatory environments and effectively communicate impact to the organization and stakeholders.

·       Ensure expertise and service to customer inquiries about Regulatory matters.

·       Facilitate seamless collaborations with R&D, Sales, Marketing and Quality teams to provide strategic input and technical guidance on regulatory requirements.

·       Secure review and approve advertising and promotional items to ensure regulatory compliance

·       Cultivate a commercial mindset and partner with customers to support customer product registrations.

·       Manage the regulatory department’s budget.

Strategic leadership

·       Develop regulatory strategies in response to commercial opportunities, regulatory changes, and new products.

·       Create product positioning strategies based on regulatory requirements in various territories.

·       Oversee regulatory aspects of business relationships, ensuring compliance and protection of corporate interests.

·       Conduct regulatory due diligence for potential and new acquisitions and advise management.

Technical Representation:

• Interpret new and existing regulatory requirements, policies, and guidance related to products and ensure compliance.
• Provide guidance on clinical study design and review clinical trials data to support health benefit statements and marketing of dietary ingredients and relevant products.
• Provide regulatory input for inspections and audits.
• Manage processes for maintaining licenses, registrations, and listings.

Leadership Role:

·       Contribute effectively to the Research & Development Leadership Team.

To succeed you must hold:

·       M.Sc. or equivalent, and a Ph.D. in a life-science field (Microbiology, Molecular Biology, Biochemistry, Food Technology). An additional leadership diploma/degree is a plus.

·       Over 10 years of strategic regulatory experience, preferably within ingredients and/or dietary supplements.

·       Proven ability to lead teams, improve standards, and implement processes.

·       Extensive experience collaborating with R&D, Quality, Sales, and Marketing.

·       Fluent in English with excellent communication (written and verbal) and people skills.

Join us at Probi and lead the regulatory affairs activities globally. Apply now!