Regulatory Affairs Manager - Shared

The Lauridsen Group

Ankeny, IA, USA

Full time

Jan 17

Full Job Description

The Lauridsen Group, Inc. (LGI), is a collection of seven independent companies with each dedicated to discovering and producing products to enhance health and nutrition. These companies have the ability and charge to be entrepreneurial, to seek out new markets, to develop new products and applications, and to discover new ways to add value through fractionation and novel applications. LGI is headquartered in Ankeny, IA and maintains fifty manufacturing and sales locations in twenty countries and sales in more than sixty countries.


Manage domestic and international regulatory affairs projects in support of strategic sales opportunities and to mitigate business risks. This includes organizing and completing required regulatory documents, arranging renewal application work and supporting compliance efforts. This individual will interact with key government officials and decision makers.

JOB QUALIFICATIONS:

Education and Experience:

  • B.S. in Animal Science, Biology, Biochemistry or other science-based training.
  • At least 5 years of quality or regulatory related work experience is desired.
  • Prior exposure to key regulators is highly desirable.

JOB DUTIES:

  • Responsible for managing regulatory projects especially for export countries as requested by the businesses and prioritized by the Director of Regulatory Technical Support.
  • Work and collaborate with distributors, sales staff and LGI colleagues in different region to define export regulatory and registration requirements. Collect and complete regulatory documents for product and facility registrations based on regional export requirements in collaboration with QA and other company personnel in a timely fashion.
  • Work effectively with individuals from USDA/APHIS/, CFIA, FDA, AAFCO and other regulatory bodies and industry associations as appropriate to move export and other regulatory projects forward.
  • Ensure proper customer documentation and regulatory files are created, maintained, and updated. Assist with maintaining and updating a database to track status of regulatory projects.
  • Keep track by country, plant and product, where LGI companies can ship products to and from and ensure valid Health Certificates, Import/Export permits are in place and renewed when needed.
  • Utilize Reliance for Doc Control and Change communications to ensure appropriate staff is informed of changes and has access to documents as needed.
  • Communicate regulatory requirements to operations, ensure product specifications meet regulatory requirements.
  • Stay abreast of changing regulatory requirements in the marketplace and communicate changes to management.
  • Working closely with the Director of Regulatory Technical Support, interpret new policies and regulations and explain their impact to management as appropriate.
  • Work closely with customer service with regulatory requirements relevant to import/export issues, e.g., tariff code reviews, Product finder questions, assist with troubleshooting.
  • Maintain a working knowledge of LGI companies’ quality and regulatory requirements and assist with APHIS inspections as needed.
  • Work with R&D on new processes as needed to maintain regulatory compliance for potential and current new markets.
  • Develop easily accessible library of documents for product and facility registrations.
  • Prepare monthly report for APC and other updates as requested by the businesses.
  • Any other duties as assigned by the Director of Regulatory Technical Support.

JOB REQUIREMENTS:

  • Project management experience needed to track status of regulatory projects.
  • Regulatory and/or import/export experience desired and previous exposure to APHIS, FDA, USDA, CFIA and other regulatory bodies a plus.
  • Ability to manage multiple tasks and projects in a changing work environment.
  • Recognized professional demeanor.
  • Excellent organizational skills.
  • High attention to detail. Ability to communicate effectively verbally and in writing with regional LGI personnel, APHIS staff, distributors, customers, sales team, and other business-related contacts.
  • Must be able to work well in a team environment and coordinate tasks/projects with others.
  • Ability to develop effective relationships with regulatory contacts
  • Maintain a high level of confidentiality related to all duties and responsibilities, such as proprietary information where required.
  • Ability to work effectively with minimum supervision.
  • Ability to operate all necessary office equipment required to accomplish job duties, such as, computers, telephones, fax machines, projectors, copiers, or other equipment to effectively complete the job.
  • Ability to understand, analyze, interpret and communicate government rules & regulations, and technical information to LGI personnel, and distributors/sales team where needed.
  • Ability to understand process and product testing procedures used by LGI including chemical, microbiological, efficacy and other tests.
  • Ability to travel domestically for inspections when needed and to trade association or training meetings.
  • Ability to work extended hours if necessary.

BASIC MENTAL REQUIREMENTS:

This job requires the capabilities to apply regulatory practices and principles required in the production of LGI companies’ products affecting a profitable and high-quality finished product. Furthermore, the incumbent for this position must have the abilities to organize and manage several tasks/projects simultaneously and possess excellent communication skills in working with a variety of business associates. This individual will need to possess a high attention to detail and the ability to analyze, interpret, and apply technical government rules and regulations to maximize global sales opportunities. The ability to work closely with and where needed train Regulatory Affairs staff and other business support personnel is a must.

WORKING CONDITIONS AND EXPOSURES:

Working conditions vary. Most of the job duties occur within a general office environment while other job duties such as inspections occur within a manufacturing plant setting with exposure to odor, noise, dust, moving machinery, and occasional contact with hazardous chemicals.

Furthermore, this position may require the incumbent to travel on business to a production plant or another country in a variety of weather conditions.

LGI participates in E-Verify

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