Associate Director, Microbiome Regulatory Science - Kennesaw, GA

Job Description

Associate Director Microbiome -  Decatur, IL; Chicago, IL: Erlanger, KY; Kennesaw, GA; or other ADM Location

Principal Responsibilities:

• Lead the development and deployment of Regulatory Science strategies for biotics and other functional ingredients across all market segments, and regions.  This includes developing and providing scientific input to ingredient permissibility, safety, efficacy, claims, and other relevant information.
• Develop and drive enterprise-wide Regulatory Science/Scientific Affairs communications to internal stakeholders for microbiome solution ingredients (live and inactivated microorganisms, and their derivates), and across different market segments including Food, Feed, Pharma, Dietary Supplements, Cosmetics, Biopesticides and Biocontrol agents applications. 
• Develop internal guidelines addressing  regulatory and scientific requirements for global microbiome ingredient safety and efficacy substantiation. In addition, manage and facilitate global regulatory submissions and approvals for market expansion, as needed.
• Provide ADM’s Senior Leadership with relevant and up-to-date status on support for ADM’s microbiome solutions portfolio.
• Represent Regulatory & Scientific Affairs representation on ADM’s Health and Wellness Clinical Trials Board (CTB), ensuring ADM’s clinical trial strategy for is aligned with the RSA global microbiome strategy. In addition, review and provide feedback on clinical trial protocols and publications.
• Track regulatory and scientific competitive intelligence, horizon scanning, and regulatory trend reports for microbiome solution ingredients and ensure business awareness of relevant risks and opportunities that may impact portfolio today or in the future.
• Partner with Regulatory Affairs, Government Relations, and R&D to develop and support the execution of internal and external advocacy strategies targeting microbiome solution ingredients. Lead ADM’s representation at national, regional and global industry trade associations and conferences on microbiome (IPA, CRN, CHPA, GPA, IPA Europe, PRI, HFMA, ILSI, ISAPP, CMA, ALANUR, ABIAD).   Strive for global regulatory harmonization and visible leadership for ADM in trade associations and industry group discussions.
• Support RSA’s due diligence for ADM’s global Mergers & Acquisitions and Joint Venture projects connected with ADM’s Microbiome Solution Ingredients.
• Provide regulatory/scientific affairs expertise into 1ADM and other similar global process projects for relevant regions.
• In partnership with R&D and Marketing, provide relevant Scientific Affairs support to internal and external marketing communications, ensuring alignment and compliance across all business units and market segments.

Qualifications:

• MS in microbiology or related science.
• 10+ years experience supporting safety, efficacy, clinical, scientific claims substantiation, labeling, etc of biotic and functional ingredients. Experience with probiotics and prebiotics is desirable.
• Basic understanding of manufacturing and global regulatory frameworks.
• Experience managing scientific dossiers for global registrations.

Before applying for an exempt, non-exempt or hourly job opportunity, you are expected to initiate position for more than 18 months, supervisor approval is not required.  a discussion and share your intentions with your supervisor.  * If you’ve been in your current * If you’ve been in your current position for less than 18 months, verbal supervisor approval is required.   ​
Hiring Manager- Ash Tiwary   ​
Recruiter- Amy Schroeder 
 

City

Kennesaw

State

GA - Georgia

Location Country

United States

About ADM

At ADM, we unlock the power of nature to provide access to nutrition worldwide. With industry-advancing innovations, a complete portfolio of ingredients and solutions to meet any taste, and a commitment to sustainability, we give customers an edge in solving the nutritional challenges of today and tomorrow. We’re a global leader in human and animal nutrition and the world’s premier agricultural origination and processing company. Our breadth, depth, insights, facilities and logistical expertise give us unparalleled capabilities to meet needs for food, beverages, health and wellness, and more. From the seed of the idea to the outcome of the solution, we enrich the quality of life the world over. Learn more at www.adm.com.