Overview
Kemin is currently hiring for a Sr. Regulatory Affairs Manager at our Des Moines, Iowa location. The Sr. RA Manager provides regulatory strategy and direction from the product concept to launch and through the product life-cycle for the U.S. market. The Sr. RA Manager will also be responsible for overseeing claim substantiation for the U.S. and international markets.
The ideal candidate will have experience working with major regulatory and government agencies such as FDA and USDA and have strong people management and decision making skills.
This role is required to work onsite in Des Moines, Iowa.
We Are Kemin
We are visionaries who see things differently and are inspired by the world around us.
We have been dedicated to using applied science to improve the quality of life for over half a century.
We are a global ingredient manufacturer that strives to sustainably transform the quality of life every day for 80 percent of the world with its products and services.
For over half a century, Kemin has been dedicated to using applied science to address industry challenges and offer product solutions to customers in more than 120 countries. Kemin provides ingredients to feed a growing population with its commitment to the quality, safety and efficacy of food, feed and health-related products to customers around the world.
Established in 1961, Kemin is a privately held, family-owned-and-operated company with more than 2,800 global employees and operations in 90 countries, including manufacturing facilities in Belgium, Brazil, China, India, Italy, Russia, San Marino, Singapore, South Africa and the United States.
As a Kemin team member, you’ll receive…
- A competitive financial package- in addition to your salary, we offer an uncapped bonus opportunity, 401k match program, and paid vacation and holidays.
- Robust health and wellness support- we are proud to offer a fitness reimbursement (for your whole family!), an on-site fitness center, restaurant with seasonal fresh food options (and the ability to order food to bring home), and free fresh fruit in break areas- to name a few.
- Continued learning opportunities- Kemin offers tuition reimbursement and recently launched a new corporate university with online and in-person training opportunities for growth and development throughout your entire career.
- The chance to give back to our world- Through our foundation of servant leadership, we are proud to offer ample service opportunities, including paid time off to do so. Kemin has a valued corporate partnership with both The World Food Programme and Habitat for Humanity, in addition to many local initiatives.
- Opportunities to support our valued educators- Kemin is a proud sponsor of the Iowa Governor's Stem Advisory Council where we fund annual teacher's awards. In addition, we have a robust internship and externship program, and frequently host student tours.
Responsibilities
- Lead and provide guidance on U.S. regulatory strategy as it relates to product development from idea through scale up, evaluation, launch, and post-launch, identifying ideal pathways to commercialize products.
- Oversee, prepare, and submit U.S. registration dossiers, with assistance.
- Monitor and communicate regulatory updates (FDA, FTC, state regulations) and intelligence to assist the business.
- Provide requirements, guidance, and review for claims, claim substantiation and labeling including but not limited to clinical trials, statistical analysis, safety, toxicology, quality requirements, and promotional materials.
- Actively participate with R&D, marketing, and technical services in the development, management, and review of clinical trials, safety and toxicological assessment process, and manage CRO trials as needed.
- Develop and keep up to date claim substantiation in collaboration with R&D, marketing, and technical services for new and existing products.
- Manage up to three direct reports.
- Perform regulatory review of internal and promotional documents in a timely manner.
- Support Kemin customers on regulatory related questions and matters.
- Serve as Kemin liaison to major regulatory agencies and involved in government agency inspections, including, but not limited to FDA, CFIA, USDA, OSHA, DOT, FAA, etc. as needed.
- Understand U.S. food and dietary supplement GMPs and work with staff, participating in audits and inspections by various customers, auditing bodies and regulatory agencies.
- Responsible for final review of approval of all product formulas and product claims for Kemin. This includes sign-off for all marketing and sales literature for Kemin products.
- Assist in management of product recalls for Kemin products.
- Attend industry trade shows and stay current on trends as they affect regulations.
- Provide budgetary planning, development, and management for the department.
- Write, maintain, and administer Regulatory Affairs disaster recovery plan, as required.
- Focus and prioritize projects, and assume responsibility for their success.
- Determine regulatory requirements and interpret relevant government regulations for Kemin products.
- Coordinate training for new employees in the Regulatory Affairs area.
- Assess and implment new technologies, processes, methods, and practices.
- Interact with Regulatory Affairs officials both internally and externally to assure the timely exchange of information.
Qualifications
- Master's degree or Ph.D in a relevant science field preferably in human nutrition, biochemistry, toxicology, or comparable discipline.
- 5-7 years of experience with managing and supporting U.S. regulations and/or scientific/technical information preparation.
- Self starter, strategic thinker with demonstrated strong analytical skills with proven ability to follow logical progression of thought.
- Demonstrated good technical writing skills through publication record.
- Excellent attention to detail required
- Ability to work independently and interact well in a team environment.
- Excellent verbal and interpersonal communication skills; ability to present ideas effectively to all levels of management
- Excellent organizational and time management skills, demonstrated prioritizing, planning and project management skills.
- Capacity to produce high quality work products across multiple projects while working under pressure and short time lines.
- Must be customer service oriented and work well with varied personalities with internal and external team members.
Kemin is an equal opportunity employer, and all reasonable accommodation will be considered.
A post-offer background check and drug screen is required.
Additional pre-employment requirements may be necessary based on position.
#LI-MN1