Head of Regulatory Affairs

Roquette is a family-owned global leader in plant-based ingredients and a leading provider of pharmaceutical excipients.

Want to help us make a difference?
Using plant-based resources, we collaborate with our customers and partners to imagine and offer ingredients to better feed people and treat patients.
Each of our ingredients responds to unique and essential needs, and they enable healthier lifestyles.

We are looking for our next Head of Regulatory Affairs - EMEA Nutrition and BioIndustry (H/F). This position will be located in Lestrem.

The Regulatory affairs Nutrition business team (RA) provide Nutrition & Bioindustry Business Group (BG) with the best assessment of risks and opportunities for our products. Regulatory Affairs (RA) interact with a large variety of services internally, such as Marketing, Public Affairs, Quality Affairs, R&D, manufacturing, as well as outside the company as RA represent Roquette in external associations and meetings with Public Authorities.

He/She is responsible for developing and leading regulatory strategies in this region to ensure successful development and commercialization of BG Nutrition & Bioindustry products.

He/she manages a regional team of qualified regulatory professionals who work closely with internal business partners, including marketing, sales, quality assurance, R&D, innovation teams and platforms, supply chain, and more, to provide proactive support and expertise to the Nutrition & Bioindustry business on Regulatory matters. This position is accountable for training and mentoring the regulatory team to be well-informed on the local business of Roquette and clear understanding of customer needs and priorities.

You will be responsible for:
- Lead the strategic planning for the region, ensuring alignment with global business objectives and cross-functional strategic plans: Develop and implement innovative and competitive regional regulatory strategies from product development to lifecycle management, in alignment with Nutrition & Bioindustry business objectives.-
- Guarantee, together with his/her team the Regulatory compliance of all existing products and innovation projects including adherence to local and regional, regulatory requirements.- Share regulatory issues to, and interface with R&D, Commercial and Marketing functions to define optimal regulatory pathways aligned with business plans, for developing opportunities and ensures compliance of marketing documentation with regulatory standards.- Active involvement with new projects and new product developments, defining regulatory strategies for the region and supporting dossier work.- Assess specific product portfolio providing regulatory advice and risk assessment/management.- Provide active customer support on regulatory matters.- Represent Roquette externally in industry associations and with relevant authorities to help shape legislative decisions, gain intelligence about regulatory changes and contributes meaningfully to building the industry's agenda. Build and maintain strong relationships with key regulatory bodies and stakeholders.- Provide regulatory updates and interpretations to internal teams and senior management about regional regulatory requirements, guidelines, and trends affecting Nutrition and Bioindustry products.- Supervise drafting of external position papers to advocate for the company's interests and coordinates influence initiatives such as those related to CODEX and ISO.

What will we love about you?

First of all, you are agile, and you have excellent communication skills and leading capabilities. You are innovative, autonomous, open-minded, strong business acumen. You are driven by performance optimization, problem-solving and results oriented.

But also:
- Master degree in food related science or food law.- Experience minimum 15 years Regulatory Affairs work experience in the Food Industry, which shall include Regulatory experience (regional or global) and experience of regulatory submissions and approvals. But also, managerial skills, with experience (at least 5 years)- Excellent social and communication skills in English and French, both written and verbal- Ability to enlighten business on how regulations impact its development or innovation and propose adapted risk management strategies / advices on opportunities- Ability to explain, communicate and turn a vision into a concrete actions plan- Extensive knowledge of EU regulatory environment.- Proven ability to manage large amounts of information, and ability to make both tactical and strategic decisions.- Experience working in a complex and matrix environment with multiple stakeholders and strong project management skills management on cross-functional teams.- Strong analytical and problem-solving abilities, with a proactive approach to identifying and resolving regulatory challenges.- Proven strong leadership, decision making and interpersonal skills and negotiation skills with health agencies.

What will you love