Senior Director of Regulatory & Scientific Affairs, Health & Wellness

Job Description

Senior Director, Regulatory and Scientific Affairs, Health and Wellness - Chicago, IL; Decatur, IL; Kennesaw, GA; or Erlanger, KY

PURPOSE OF JOB:
The Senior Director RSA H&W is the senior Regulatory & Scientific Affairs (RSA) role responsible for the ADM Health and Wellness Portfolio.  This role sits on the Global ADM RSA team, as well as the H&W Leadership Team and plays a vital role in shaping the strategy and direction of the business.   ADM’s H&W business offers a robust portfolio of ingredient opportunities for humans and animals, including pre-pro-post biotics, botanicals and naturally based ingredients.  These include 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 and natural preservation systems.

This role leads the Regulatory & Scientific Affairs functional interface with the business, helps set functional priorities internally as well as externally through advocacy.  

• Maximizes the internal regulatory network within ADM globally with shared functional resources, and works to direct the RSA approach globally for H&W.
• Engage with external partners to represent the company and defend its interests.

• Oversight of functional team and direct according to business priorities for product stewardship, market entry, claims, and maintenance of the regulatory aspects of the portfolio.
• Strategic Regulatory & Scientific Strategy lead for Global H&W business.
• Work closely with the RSA corporate functional community to lead function-to-business partnership in terms of division RSA organizational design and resourcing.  Leverage cross-division functional responses and conduit to commercial strategies.
• Work closely with the Regulatory Compliance and Performance team to develop and evaluate the business metrics as well as the KPI’s for the division.
• Work with H&W Leadership and the function to align on the divisional RSA budget.
• Support due diligence required for M&A and JV activities as identified and requested by RSA and Business leadership.
• Ensure that the RSA H&W teams are maintaining the regulatory database(s) for business partners (Operations, Marketing, Products Development and Applications, Research and Innovation).
• Advise and support quality, marketing and product management departments in ensuring regulatory compliance of products and marketing tools.
• Check regulatory status of new ingredients and new products versus regulation applicable in the region and liaise with global regulatory network for other regions.
• Advise quality department for products labelling, MSDS and quality/regulatory statements following ADM standards.
• To reply to regulatory enquiries on ADM’s products.
• To contribute to ADM’s working groups on regulatory topics.

• Actively participate (e.g. CRN, IPA) in consortia that advance harmonization, and market access for the ADM portfolio.
• Support the preparation of authorization and renewal dossiers in partnership with Science & Technology and Marketing and Product Management.
• Define regulatory strategy to accelerate market launch of new specialty offerings, ingredients and finished products in collaboration with regional teams and external consultants.

• Engage with external partners (regulatory bodies, trade associations) to represent the company and defend ADM’s aligned interests (e.g. CRN, IPA).
• Provide advice and act proactively to anticipate any regulatory change impacting the business.

• University degree in relevant scientific or regulatory area (e.g. Biology, Chemistry, Nutrition), graduate degree preferred or equivalent experience.

EXPERIENCE AND SKILLS:

• Preferred more than 15 years of experience working with U.S. regulation of food and/or dietary supplement ingredients or products.
• Global Regulatory Affairs experience.
• Leadership and team management experience.
• Ability to work in a team environment and having a cross-cultural approach.
• Strong, independent analytical and problem-solving skills. 
• Excellent communication skills and a very good command of both written and spoken English.
• Computer Skills and excellent user knowledge in business relevant software (SAP, Microsoft Office Package).
• Business Acumen.
• Recognized by peers as source of knowledge.
• Attention