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Kemin Industries · 2 weeks ago

Associate Director, Regulatory/Scientific Affairs and Quality

Des Moines, IA

Full-time

Onsite

Lead/Staff, Director/Executive

5+ years exp

Kemin Industries is a global biotechnology company dedicated to improving the quality of life for people, pets, and the planet. The Associate Director of Regulatory/Scientific Affairs and Quality will lead regulatory and quality teams, ensuring product compliance and overseeing regulatory changes while supporting innovation and commercialization efforts.

BiotechnologyFood and BeverageSustainability

Responsibilities

Responsible for leading and establishing direction for the business unit Regulatory Affairs (RA) and Quality Assurance (QA) department and working cross-functionally across business units and within the business unit to assure regulatory and quality compliance for the products marketed and sold by the primary business unit

Responsible for establishing and managing the RA/QA budget and departmental strategies to support the overall strategic plan

Work cross-functionally and provide regulatory, scientific and quality expertise and support through all stages of the innovation process, ensuring the safety, freedom-to-operate, and regulatory compliance of ingredients, contaminant legislations, and packaging materials

Ensure that Kemin Health ingredients, formulas, products, labels, packaging, promotional materials, and marketing communications comply with relevant local and global regulations as well as Kemin policies and guidelines in collaboration with Commercial and R&D departments

Lead and execute on regulatory innovative strategies for Kemin products deemed necessary to achieve business outcomes such as global regulatory approvals and clearance for Kemin Health ingredients, labels, and claims

Serve as official Kemin liaison to regulatory entities, including, but not limited to US FDA, EFSA, Health Canada, ANVISA, etc

Responsible for final review and approval of all product formulas as well as review of commercial collateral administered through Kemin’s Permission to Publish (PTP) program

Support Kemin Health customer needs and/or create collateral related to regulatory, claims, and quality compliance as it related to Kemin Health ingredients

Oversee QA for all Kemin Health products including food safety and regulatory compliance programs and systems (HACCP, GMP, Environmental Monitoring, Pest Control and Sanitation Program; hold and reject; product recovery, allergens, recalls and inspections (internal and external)

Oversee and work closely with Central Operations and Quality on audits (regulatory and customer), supplier qualification, non-compliant product, 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 as it relates to evolving business needs

Responsible for final review and approval of all product formulas, and product claims,, quality questions, and claim-language freedom to operate decisions for business unit product portfolio

Determine regulatory requirements and interpret relevant government regulations to support the business unit product portfolio. Demonstrates servant leadership in all aspects of managing the RA/QA department including performance discussions, managing priorities, hiring of staff

Qualification

Regulatory AffairsQuality AssuranceQuality Management SystemsRegulatory ComplianceNutraceuticals ExperienceU.S. Regulations KnowledgeGlobal Regulations KnowledgeInfluencing SkillsTime ManagementOrganizational SkillsLeadership SkillsPresentation Skills

Required

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 in key regions (EU, Canada, Mexico, Brazil, APAC, Australia) as they relate to dietary ingredients including but not limited to ingredient manufacturing, safety, contaminants, quality, packaging/labels, claims and claim substantiation

Experience with supporting customers on regulatory and quality-related matters

Experience and knowledge/skills related to Quality Management Systems such as GMPs, ISO, HACCP

Must have excellent time management and organization skills, a high energy level, and a sense of commitment and urgency to ensure obligations are met

Excellence in presenting, influencing, fostering relationships across global cultures

Ability to lead and develop people, previous experience managing people required

Experience working with variety of government agencies

Experience in drafting and assembling successful regulatory dossiers that result in approval/market clearance by the US and/or foreign regulatory authorities

Strategic and business-impact mindset

Ability to influence, articulate and propose alternatives to critical decisions without compromising quality and safety

Travel up to 20% including both regional and global

Benefits

Competitive Financial Package: Enjoy a rewarding salary, uncapped bonus opportunities, a 401k match program, and generous paid vacation and holidays.

Health and Wellness Support: Stay fit and healthy with our fitness reimbursement for the whole family, access to an on-site fitness center, a restaurant offering seasonal fresh food options, and free fresh fruit in break areas.

Career Development and Advancement: Unlock your potential with opportunities for growth and development throughout your entire career.

Continued Learning Opportunities: Grow your skills with our in-house learning platforms, offering thousands of training resources both live and online, and take advantage of tuition reimbursement for external post-secondary pursuits.

Service Opportunities: Make a positive impact with paid time off for service, partnerships with The World Food Programme and Habitat for Humanity, and local community initiatives.