Regulatory Affairs Team Manager – Short-term Contract (8 months, starting January) - W/M

Lesaffre; Marcq-en-Barœul; Sur place; EUR 80 000 - 100 000; Plein temps

Résumé du poste

A global leader in fermentation is seeking a Regulatory Affairs Team Manager to ensure compliance for Gnosis products. You will lead a team and coordinate with various stakeholders, ensuring alignment with regulatory objectives. The ideal candidate has a Master's degree and at least 7 years of experience in regulatory affairs. Join a company that values diversity and offers an enriching work environment.

Prestations

Enriching work environment

Commitment to diversity

Qualifications

• Minimum 7 years of experience in regulatory affairs.
• Knowledge of regulatory frameworks for food/food supplements or pharmaceuticals.
• Expertise in developing regulatory strategies and risk management.

Responsabilités

• Ensure local regulatory compliance of Gnosis products.
• Provide actionable guidance to team members.
• Monitor and support implementation of team roadmap.
• Manage regulatory inquiries and responses.
• Represent Gnosis at trade association meetings.

Connaissances

Regulatory frameworks knowledge

Team management

Organizational skills

Cross-functional collaboration

Fluent in English

Formation

Master's degree in a scientific or technical field

Description du poste

Company Description

As a global key player in yeasts and fermentation, Lesaffre designs, manufactures and markets innovative solutions for Baking, Food taste & pleasure, Health care and Biotechnology.

Family group born in northern France in 1853, now a multi-national and a multicultural company, Lesaffre is committed to working with confidence to better nourish and protect the planet.

In close collaboration with its clients and partners, Lesaffre employs 11,000 people in more than 50 countries.

Lesaffre achieves a turnover of 3 billion euros.

For over 30 years, Lesaffre has been involved in Human Health & Nutrition as part of its ambition to Better Nourish and Protect the Planet.

In November 2018, Lesaffre acquired Gnosis Advanced Biotech and officially combined it with Lesaffre Human Care to form a new Business Unit named Gnosis by Lesaffre.

Gnosis by Lesaffre is the business unit dedicated to human health.

At Gnosis by Lesaffre, we are committed to cultivating and to delivering nutritional actives, biotics, and nutritional yeasts that benefit human health and wellbeing, thanks to the power of microorganisms and biotransformation processes like fermentation. Put differently, we explore life to improve living.

Our vision: At Gnosis by Lesaffre, we strive for a world that moves better, digests better, ages better, feels better, and, ultimately, lives better thanks to microorganisms and fermentation.

Job Description

In order to cover a maternity leave, we are looking for a Regulatory Affairs Team Manager. In this position, you will play a pivotal role in leading a dedicated team responsible for ensuring the regulatory compliance of Gnosis ingredients across various regions. You will be responsible for aligning your team's activities with the strategic roadmap of the Regulatory & IP department, monitoring objectives, and driving efficient operations. Serving as the primary representative for your team, you will interface with internal stakeholders across the organization, as well as external partners, to achieve the defined goals. This position reports to the Regulatory Director of the Business Unit and is based in Lille.

Day-to-Day Responsibilities

• Ensure local regulatory compliance of Gnosis products on the market.
• Provide clear, actionable guidance to your team members, monitor deliverables, challenge deadlines, and ensure solutions are found where necessary.
• Monitor and support the implementation of the team roadmap, ensuring resources and budgets are aligned.
• Ensure that all team members understand the team's objectives and work collaboratively to achieve them.
• Establish and maintain effective communication systems within the team, including regular planning and review meetings.
• Oversee the regulatory affairs ticketing system, ensuring timely and effective responses to customer inquiries and requests, and driving continuous improvement.
• Ensure a high level of regulatory support towards Gnosis customers and interact directly with them and the sales team.
• Arrange the proper management and organization of Gnosis product registration for new markets and applications.
• Ensure good relationship management with our external consultants and lawyers.
• Communicate project status and ensure alignment with sales and marketing teams.
• Actively participate in Lesaffre's regulatory network, collaborating with other business units, GRADs, and regional teams.
• Represent Gnosis By Lesaffre during trade association meetings and participate in sharing Gnosis' position when necessary.
• Coordinate the review of marketing brochures with necessary regulatory experts.

Qualifications

Qualifications & Skills:

• Master's degree in a scientific or technical field, preferably in pharmacy, food science, or a relevant life science discipline.
• Minimum 7 years of experience in regulatory affairs within the food supplement, pharmaceutical, or food industries, including management of a team.
• Demonstrated knowledge and understanding of the regulatory frameworks applicable to food/food supplements or pharmaceuticals worldwide.
• Expertise in developing and implementing regulatory strategies, as well as risk management and assessment in a regulatory context.
• Strong understanding of the scientific and technical aspects of regulatory topics.
• Excellent organizational skills to set up monitoring tools, records, and reporting systems.
• Fluent in English, both written and verbal, with the ability to communicate effectively with international stakeholders.
• Capacity to collaborate effectively with cross-functional teams, aligning them towards common regulatory goals and objectives.

Additional Information

What Lesaffre can offer you :

• Join a family business rich in a long history with human-oriented values with a mission: To Nourish and Protect our Planet,
• Evolve in an enriching work environment and a multicultural context

At Lesaffre, diversity is a strength that enriches our culture and our teams. We are committed to offering you a work environment where you can thrive, regardless of your background, gender, age or abilities. We encourage all applications, as we believe that diverse perspectives strengthen our ability to innovate and meet the challenges of tomorrow.