Sr Director, Regulatory & Scientific Affairs, Health & Wellness

Job Description

Senior Director, Regulatory & Scientific Affairs, Health & Wellness - Chicago, IL

PURPOSE OF JOB:
The Senior Director, Regulatory & Scientific Affairs, Health & Wellness (H&W) is the most senior Regulatory & Scientific Affairs (RSA) role responsible for the ADM Health and Wellness portfolio.  This role sits on the Global ADM RSA leadership team, as well as the H&W Leadership Team and plays a vital role in shaping and executing the regulatory strategy and direction of global ADM H&W business. ADM’s H&W business consists of a robust portfolio of ingredients and products for both humans and animals, including pre-pro-post biotics, supplements, botanicals and naturally based ingredients. The H&W portfolio includes microbiome solutions and specialty health products and ingredients such as prebiotic dietary fibers, plant- and nutritional oils, mixed tocopherols and vitamin E, sterols, sterol esters, isoflavones, natural preservation systems, etc.

Responsibilities:

• Directs the global H&W regulatory team across North America, Europe and Asia
• Leads the Regulatory & Scientific Affairs functional interface and engagement with the H&W business unit
• Leverages RSA to protect ADM’s H&W business and enable growth and innovation of the ADM’s H&W business
• Collaborates with the broader regulatory community and partner functions within ADM to advance the H&W business needs
• Engages with external partners, customers and industry associations, to advance ADM’s H&W business vision and mission

DUTIES AND RESPONSIBILITIES:
Supporting the business

• Oversight and direction of the RSA H&W team in alignment with business priorities and regulatory requirements to enable dossier development, regulatory submissions, claims substantiation, enabling market entry and maintenance of regulatory aspects across the portfolio
• Develop and deploy RSA strategy, annual business plan and ‘big rocks’ for the global H&W business
• Collaborate and contribute to the Corporate RSA leadership and global function, enabling function-to-business partnership, resource and expertise optimization, driving efficiency and effectiveness, etc
• Work with the function and H&W Leadership to align on annual people, trade association, travel, consultant, etc budget
• Support M&A and JV due diligence as requested by RSA and H&W business leadership
• Ensure that the RSA H&W teams are maintaining current and relevant regulatory database(s) for business partners (Operations, Marketing, Product Development and Applications, R&D, innovation)
• Collaborate with the Animal/Pet Nutrition RSA team to support the H&W Pet ingredients and products
• Advise and support quality, marketing and product management departments to ensure regulatory compliance of raw materials, products and communication/marketing materials
• Collaborate with global regulatory network to confirm regulatory compliance for new ingredients and products based on country of sale and intended use
• Ensure regulatory compliance of H&W portfolio including MSDS, labelling, claims, declarations, etc in alignment with regulatory and other standards/requirements for country of sale and intended use
• Leverage and implement processes, systems and tools to drive efficiency and effectiveness
• Keep RSA H&W community and H&W business updated on emerging issues, key accomplishments, regulatory barriers, etc
• Implement appropriate RSA H&W engagement, training and succession initiatives
• Reply to internal and external regulatory enquiries on ADM H&W products adequately and timeously

Ensuring market authorization for ingredients and finished products

• Actively participate in H&W Industry Associations to advance regulatory opportunities and market access for the ADM H&W portfolio
• Support the preparation of authorization and renewal dossiers in partnership with key functions; Science & Technology, Marketing, Product Management, etc
• Define regulatory strategy to accelerate market launch of new specialty offerings, ingredients and finished products in collaboration with regional teams and external consultants

Professional Associations network

• Engage with external partners (regulatory bodies, trade associations) in coordination with the global RSA leadership and regional H&W teams to represent the company and advance ADM’s H&W priorities
• Proactively identify and socialize key scientific and regulatory headwinds and tailwinds that may impact ADM’s H&W business/portfolio and advice the business to mitigate risks and leverage opportuniti