Regulatory Affairs Manager jobs in Iowa

Regulatory Affairs Manager manages regulatory matters and executes the strategy to ensure the organization complies with applicable regulations. Implements processes and systems to ensure that all necessary licensing, filings, certifications, and permits are processed and monitored. Being a Regulatory Affairs Manager utilizes established monitoring policies and procedures to ensure compliance with existing regulations. Anticipates new or changing regulations and coordinates with internal stakeholders to develop strategies to address changes in product, operations, or testing requirements. Additionally, Regulatory Affairs Manager investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to a director. The Regulatory Affairs Manager manages subordinate staff in the day-to-day performance of their jobs. True first level manager. Ensures that project/department milestones/goals are met and adhering to approved budgets. Has full authority for personnel actions. To be a Regulatory Affairs Manager typically requires 5 years experience in the related area as an individual contributor. 1 - 3 years supervisory experience may be required. Extensive knowledge of the function and department processes. (Copyright 2024 Salary.com)

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Senior Regulatory Affairs Manager
  • Kemin
  • Des Moines, IA FULL_TIME
  • 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

  • Just Posted

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Regulatory Affairs Assistant
  • Kemin
  • Des Moines, IA FULL_TIME
  • Overview Kemin Nutrisurance is seeking a Regulatory Affairs Assistant to join their team! In this role, you will be responsible for the administrative support functions for the IPRA team. Nutrisurance...
  • 22 Days Ago

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Regulatory & Government Affairs Specialist
  • Mom's Meals
  • Ankeny, IA FULL_TIME
  • The Regulatory Specialist will evaluate, maintain, and report on compliance with applicable regulatory guidelines in order to provide regulatory guidance to the company. Please note this position requ...
  • 13 Days Ago

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Executive Director, Advertising & Promotions Regulatory Affairs
  • Bausch Health
  • Iowa, IA FULL_TIME
  • Bausch Health is a global company that develops, manufactures, and markets a differentiated product portfolio across multiple high-growth therapeutic areas including Gastroenterology, Generics, Neurol...
  • 11 Days Ago

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Executive Director, Advertising & Promotions Regulatory Affairs
  • Bausch Health
  • Quad Cities, IA FULL_TIME
  • Bausch Health is a global company that develops, manufactures, and markets a differentiated product portfolio across multiple high-growth therapeutic areas including Gastroenterology, Generics, Neurol...
  • 11 Days Ago

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Executive Director, Advertising & Promotions Regulatory Affairs
  • Bausch Health
  • Dubuque, IA FULL_TIME
  • Bausch Health is a global company that develops, manufactures, and markets a differentiated product portfolio across multiple high-growth therapeutic areas including Gastroenterology, Generics, Neurol...
  • 11 Days Ago

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Regulatory Affairs Manager
  • Lumicity
  • This opportunity is with a company revolutionizing the medical device industry with its cutting-edge technologies and co...
  • 3/28/2024 12:00:00 AM

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Regulatory Affairs Manager (Chemical Labeling)
  • Astrix
  • Countryside, IL
  • The Regulatory Labeling Manager develops, coordinates, and implements regulatory strategies for products that require go...
  • 3/28/2024 12:00:00 AM

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Regulatory Affairs Manager
  • Daikin Comfort
  • Waller, TX
  • Regulatory Affairs Manager Daikin Comfort Technologies Manufacturing, L.P. is seeking a skilled individual for our Regul...
  • 3/27/2024 12:00:00 AM

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Regulatory Affairs Manager
  • Dental Technologies Inc
  • Lincolnwood, IL
  • Job Description Job Description Job Title: Regulatory Affairs Manager Department: Quality Assurance Reports To: Vice Pre...
  • 3/27/2024 12:00:00 AM

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Global Regulatory Affairs Manager II
  • Yoh, A Day & Zimmermann Company
  • Fort Worth, TX
  • Job Description Job Description Global Regulatory Affairs Manager II - Fort Worth 9 month contract W2 Pay Rate: $55.00 -...
  • 3/27/2024 12:00:00 AM

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Regulatory Affairs Manager
  • Beacon Hill Staffing Group
  • San Fernando, CA
  • **Role is Fully Onsite to Northridge, CA** ROLE SUMMARY To support the our business in maintaining regulatory compliance...
  • 3/25/2024 12:00:00 AM

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Regulatory Affairs Manager
  • Advanced Respiratory Technologies, Inc.
  • Pittsburgh, PA
  • Advanced Respiratory Technologies, Inc. is a medical device company located outside of Pittsburgh, PA that is developing...
  • 3/25/2024 12:00:00 AM

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Regulatory Affairs Manager
  • Alameda Health System
  • Oakland, CA
  • Summary SUMMARY: Plans, coordinates, monitors compliance with federal, state and local regulations; manages accreditatio...
  • 3/25/2024 12:00:00 AM

Iowa (/ˈaɪəwə/ (listen)) is a state in the Midwestern United States, bordered by the Mississippi River to the east and the Missouri River and Big Sioux River to the west. It is bordered by six states; Wisconsin to the northeast, Illinois to the east, Missouri to the south, Nebraska to the west, South Dakota to the northwest and Minnesota to the north. In colonial times, Iowa was a part of French Louisiana and Spanish Louisiana; its state flag is patterned after the flag of France. After the Louisiana Purchase, people laid the foundation for an agriculture-based economy in the heart of the Corn...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Manager jobs
$131,480 to $185,451

Regulatory Affairs Manager in Wichita Falls, TX
Other names for this job might include Clinical Trials Systems Administrator, Global Regulatory Affairs Manager, Regulatory Administrator, Regulatory Affairs Director, Regulatory Affairs Manager, Regulatory Affairs Portfolio Leader, Regulatory Consultant, Regulatory Leader, Regulatory Process Manager, Regulatory Product Manager.
January 17, 2020
Regulatory Affairs Manager in Baltimore, MD
Lead strategic contributions and initiatives to develop regulatory services and improve current processes and procedures.
January 18, 2020
Regulatory Affairs Manager in Fort Lauderdale, FL
Regulatory Domain Support for business development, including solutioning and developing innovative solutions, creation of materials for and participation in sales pursuits, key client meetings, bid defences for RFIs and RFPs.
December 04, 2019