Regulatory Affairs Associate - Shared

Lauridsen Group•Ankeny, IA

12d

About The Position

As part of Lauridsen Group Inc. (LGI), LGI Services supports a portfolio of businesses dedicated to improving the effectiveness of the global food system. These efforts are guided by core values of trust, collaboration, and innovation. Lauridsen Group Inc. is comprised of seven independent companies, each operating with an entrepreneurial mindset, actively pursuing new markets, developing innovative products and applications, and identifying new ways to create value. LGI is headquartered in Ankeny and operates approximately sixty manufacturing and sales locations across twenty countries, with products sold in more than sixty countries worldwide. The purpose of this position is to provide accurate and timely regulatory support to LGI’s businesses.

Requirements

Bachelor’s degree in a science field (e.g. Microbiology, Chemistry, Biochemistry).
Min of 3-5 years of work experience preferably in a regulatory affairs or quality related role or with International trade of regulated ingredients (APHIS, CFIA etc.).
Good work history and excellent professional demeanor expected.
Computer experience and good English language skills required.
Capable of reading and interpreting legal information and analyzing technical information/data
Ability to work in a fast pace changing environment and manage multiple tasks simultaneously
Great attention to accuracy and detail required
Good organizational skills
Effective communication and writing skills with corporate staff as well as customers of LGI businesses.
Proficient English skills.
Competent in the use of computers and software packages such as MS Word, Excel, PowerPoint, MS Teams.
Ability to operate all office equipment required to accomplish job duties such as computers, copiers, and telephone systems.
Ability to remain calm and professional during peak periods of activities.
Ability to work overtime as needed.
Ability to provide support in other work-related areas as needed.

Nice To Haves

Spanish or Chinese language skills a plus.
Knowledge of MS Project management, Power BI and Reliance desirable.

Responsibilities

Complete regulatory submission packages for new product registrations and facility approvals/renewals in the US and internationally as identified by the Regulatory Affairs Manager.
Interact and communicate across functional departments and businesses to gather information for these submissions.
Support Customer Service with Import/Export needs such as selection of appropriate Health Certificates, confirmation of language on Health Certificates, assisting with researching HTS codes and other support documents as needed.
Assist with applications for import/export permits for ongoing product shipments, and their annual renewals when needed.
Draft customer statements in support of the businesses as requested by Regulatory Affairs Manager and Director of Regulatory Technical Support and review process by which frequently asked documents could be shared more efficiently.
Assist with customer documents such as PIBs, letters, and labels as instructed by the Regulatory Affairs Manager.
Electronically file documents in support of regulatory submissions and facility registrations/renewals under restricted company files and Reliance program as instructed
Help keep regulatory files, spreadsheets/databases, calendars, and expiration dates organized.
Develop new SOPs and review and update existing SOPs as needed.
Identify ways to improve current processes within the regulatory team.
Compose monthly reports, develop spreadsheets, manage key project timelines, create presentations, and provide other administrative support as needed.
Keep abreast of regulatory developments and attend appropriate webinars, classes or workshops to further the knowledge base and skills in global regulatory affairs.
All other tasks as assigned.