Associate Director, Regulatory/Scientific Affairs and Quality

Kemin • Des Moines, IA

103d

About The Position

Kemin Health is hiring an Associate Director of Regulatory/Scientific Affairs and Quality! In this role, you will be responsible for leading the business units’ regulatory affairs (RA) and quality assurance (QA) teams by proactively identifying and managing regulatory/quality risks and opportunities aligned with strategic direction and priorities of the business. This individual will be responsible for overseeing product compliance and registrations at state, national, and international levels. They will monitor and influence regulatory changes, support product safety, substantiate claims, and ensure label compliance. Additionally, they will provide guidance throughout all stages of innovation and commercialization, support global customers on regulatory and quality-related matters, and ensure the quality compliance of the business unit's product portfolio globally.

Requirements

• Undergraduate degree with 10+ years of experience in dietary ingredients, nutraceuticals, or food ingredient company.
• OR an advanced degree in science or legal field with at least 5+ years of experience in dietary ingredients, nutraceuticals, or food ingredient company.
• Strong experience and understanding of U.S. (State and Federal) and relevant global laws and regulations.
• Experience with supporting customers on regulatory and quality-related matters.
• Experience and knowledge/skills related to Quality Management Systems such as GMPs, ISO, HACCP.
• Excellent time management and organization skills.
• High energy level, and a sense of commitment and urgency.
• Excellence in presenting, influencing, fostering relationships across global cultures.
• Ability to lead and develop people, previous experience managing people required.
• Experience working with a variety of government agencies.
• Experience in drafting and assembling successful regulatory dossiers.
• Strategic and business-impact mindset.
• Ability to influence, articulate and propose alternatives to critical decisions.

Responsibilities

• Lead and establish direction for the business unit Regulatory Affairs (RA) and Quality Assurance (QA) department.
• Work cross-functionally across business units to assure regulatory and quality compliance for products marketed and sold.
• Establish and manage the RA/QA budget and departmental strategies to support the overall strategic plan.
• Provide regulatory, scientific and quality expertise and support through all stages of the innovation process.
• Ensure compliance of Kemin Health ingredients, formulas, products, labels, packaging, promotional materials, and marketing communications with relevant regulations.
• Lead and execute on regulatory innovative strategies for Kemin products to achieve business outcomes.
• Serve as official Kemin liaison to regulatory entities, including US FDA, EFSA, Health Canada, ANVISA, etc.
• Responsible for final review and approval of all product formulas and commercial collateral.
• Support Kemin Health customer needs related to regulatory, claims, and quality compliance.
• Oversee QA for all Kemin Health products including food safety and regulatory compliance programs.
• Oversee and work closely with Central Operations and Quality on audits, supplier qualification, and consumer complaints.
• Oversee quality certifications including Kosher, Halal and non-GMO Project Verification.
• Stay abreast of the changing regulatory, legal, quality and competitive landscape.
• Assess and prepare in-depth regulatory assessments and opinions.
• Demonstrate servant leadership in managing the RA/QA department.

Benefits

• Competitive financial package including uncapped bonus opportunity and 401k match program.
• Robust health and wellness support including fitness reimbursement and on-site fitness center.
• Tuition reimbursement and corporate university for continued learning opportunities.
• Paid time off for service opportunities through corporate partnerships.
• Support for educators through funding teacher's awards and internship programs.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Bachelor's degree
• Number of Employees: 1,001-5,000 employees