About BioGaia
BioGaia is a Swedish world-leading probiotics company that has pioneered microbiome research for 35 years. BioGaia’s products, based on L. reuteri bacterial strains, are among the most scientifically validated worldwide. Our product portfolio spans all life stages, from infants to adults, and covers gut health, oral health, and immune health.
Purpose and Responsibilities
The Director Regulatory Affairs leads BioGaia’s Regulatory Affairs function, ensuring regulatory compliance, strategic guidance, and effective market support across BioGaia’s global product portfolio. The role serves as BioGaia’s principal regulatory advisor and enables compliant product registration, commercialization, scientific communication, and marketing across relevant markets.
A central part of the role is to help BioGaia communicate the scientific foundation of its products responsibly and effectively to consumers and healthcare professionals. The Director provides practical, proportionate, and risk-based advice that supports informed commercial decisions while protecting BioGaia’s integrity, reputation, and license to operate.
Main Responsibilities
Regulatory Strategy and Compliance
- Develop and implement global regulatory strategies aligned with BioGaia’s business objectives.
- Maintain expert knowledge of laws, regulations, and industry guidance applicable to food, dietary supplements, probiotics, labeling, claims, and related product categories in the EU and other key markets.
- Provide regulatory leadership in product development, innovation, market entry, and lifecycle management projects.
- Assess regulatory risks and opportunities relating to products, ingredients, claims, labeling, packaging, and market expansion.
- Monitor emerging regulatory developments and provide clear recommendations on their strategic and commercial implications.
Consumer and Healthcare Professional Marketing
- Partner closely with Marketing, Medical Affairs, Legal, Science, Commercial teams, and local Managing Directors to develop responsible and effective product communication strategies.
- Provide regulatory review and risk assessment of consumer-facing and healthcare professional advertising, promotional materials, digital content, educational materials, campaigns, and product messaging.
- Advise on health claims, other product claims, scientific substantiation, and the use of clinical evidence in communications across markets and channels.
- Translate complex and differing regulatory requirements into practical, commercially relevant guidance and viable options for the business.
- Apply sound judgment and a proportionate, risk-based approach in situations where the regulatory position is complex, evolving, or not clear-cut.
- Establish efficient governance, standards, and review processes for consumer and healthcare professional communications.
- Support local markets, subsidiaries, and distribution partners with guidance on claims, promotional practices, labeling, and scientific communications.
Business and Market Support
- Support product registrations, notifications, regulatory documentation, and market access activities across BioGaia’s global markets.
- Identify efficient and responsible regulatory pathways that support innovation, commercialization, and shorter time-to-market.
- Act as a trusted advisor to senior leadership on material regulatory matters, business opportunities, and risks.
- Present significant regulatory developments, risks, and recommendations to executive leadership and, when relevant, the Board of Directors.
- Represent BioGaia in interactions with authorities, trade associations, industry organizations, and other external stakeholders.
Team Leadership and Operational Excellence
- Lead, develop, and coach the Regulatory Affairs team, creating clear priorities, accountability, engagement, and strong professional capability.
- Ensure effective resource planning, succession planning, and delivery against business-critical priorities.
- Drive continuous improvement of regulatory systems, tools, processes, and ways of working.
- Manage the Regulatory Affairs budget and monitor the function’s operational performance.
- Promote a collaborative, pragmatic, and business-oriented regulatory culture across the organization.
Experience
- Significant senior-level Regulatory Affairs experience in food supplements, probiotics, nutrition, consumer health, or a closely related field.
- Deep knowledge of the regulatory environment for food and dietary supplements, including claims, labeling, advertising, and consumer and healthcare professional communications.
- Strong knowledge of EU requirements and experience navigating regulatory requirements across international markets.
- Demonstrated experience providing regulatory advice on consumer marketing, healthcare professional communications, product positioning, and claims strategies.
- Proven leadership experience, including developing teams and building effective cross-functional relationships.
- Experience advising senior executives and presenting complex matters clearly to senior decision-makers.
- A relevant university degree or equivalent professional qualification.
- Excellent written and verbal communication skills in English.
Personal Profile & Key Objectives
Personal Profile
- Commercially minded and able to see Regulatory Affairs as an enabler of responsible business growth.
- Pragmatic and solution-oriented, with sound judgment and the ability to distinguish material risks from theoretical concerns.
- Confident in making clear recommendations and explaining the rationale behind them.
- Collaborative and skilled at building trust across scientific, commercial, legal, and operational functions.
- Strategic while remaining sufficiently hands-on to provide practical direction.
- High professional integrity, courage, and accountability.
Key Objectives
- Ensure BioGaia’s products, labeling, consumer communications, and healthcare professional marketing activities meet applicable regulatory requirements in relevant markets.
- Enable scientifically credible, responsible, and commercially effective product communications.
- Support efficient regulatory pathways that accelerate innovation, market entry, and product lifecycle activities.
- Build a high-performing Regulatory Affairs function that provides timely, pragmatic, and value-adding support to the business.
- Strengthen regulatory awareness and sound risk-based decision-making across the organization.
