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

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

Résumé du poste

A global food and nutrition company is seeking a Regulatory Affairs Team Leader in Lille. The ideal candidate will oversee regulatory compliance for Gnosis ingredients and manage a dedicated team. Applicants should have a Master's degree and 7+ years in regulatory affairs within food or pharmaceutical sectors. This full-time role offers the chance to work in a multicultural environment and contribute to important industry objectives.

Prestations

Enriching work environment

Multicultural context

Qualifications

• Minimum 7 years experience in regulatory affairs within relevant industries.
• Knowledge of regulatory frameworks for food and pharmaceuticals worldwide.
• Strong organizational skills to set up monitoring tools and reporting systems.

Responsabilités

• Ensure local regulatory compliance of Gnosis products.
• Monitor and support implementation of the team roadmap.
• Oversee the regulatory affairs ticketing system for timely responses.
• Act as primary representative for team with internal and external stakeholders.
• Participate in Lesaffre's regulatory network.

Connaissances

Proofreading

FDA Regulations

Manufacturing & Controls

Biotechnology

Clinical Trials

Research & Development

GLP

cGMP

Product Development

Chemistry

Writing Skills

Formation

Master's degree in a scientific or technical field

Description du poste

In order to cover a maternity leave we are looking for a Regulatory Affairs Team 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 teams 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 teams 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 Lesaffres 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

• Masters 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.

Remote Work: No

Employment Type: Full-time

Key Skills

Proofreading,Adobe Acrobat,FDA Regulations,Manufacturing & Controls,Biotechnology,Clinical Trials,Research & Development,GLP,cGMP,Product Development,Chemistry,Writing Skills

Department / Functional Area: Legal

Experience: years

Vacancy: 1