Regulatory Affairs Specialist

Lauridsen Group - Ankeny, IA

Full-time - Mid Level

Ankeny, IA

11-50 employees

Food Manufacturing

About the position

The Regulatory Affairs Specialist at Lauridsen Group Inc. is responsible for ensuring compliance with applicable regulations for both new and existing products. This role involves implementing internal audits, notarizing compliance reports, and managing regulatory work processes. The Specialist will stay updated on new laws and regulations, providing guidance to organizational leadership on their potential impacts. This position is primarily onsite at the corporate headquarters in Ankeny, Iowa, with some hybrid flexibility.

Responsibilities

• Monitor global regulations in all regions where the company operates or distributes products.
• Ensure adherence to regulatory guidelines and standards, including cGMP, ICH, USP, ISO, GCP, and GLP.
• Collect, organize, and evaluate scientific data for regulatory submissions.
• Advise on legal and scientific requirements for global filing processes, including FDA, EU, APAC, and China.
• Prepare and submit regulatory documents to agencies and manage follow-up negotiations to secure marketing authorizations.
• Review product packaging, advertising, and marketing materials for regulatory compliance prior to commercial distribution.
• Develop and strategize plans to bring products to market while adhering to applicable regulations.
• Support internal and external regulatory audits to ensure site compliance with relevant requirements.
• Assist with qualification and validation protocols.
• Perform other duties as needed to support company regulatory needs.

Requirements

• Bachelor's degree in a relevant field such as Regulatory Science, Biotechnology, Pharmacology, Quality Management, Engineering, or a related field required.
• Minimum 3 years or more experience in Regulatory Science, nutraceutical and/or pharmaceutical industry required.
• Industry experience with Quality Management Systems (QMS) is required.
• Familiarity with FDA filing requirements such as DMF, NDA, ANDA, MAA required.
• Experience with EU filings and procedures such as CP, DCP, MRP, NP, EDQM and CEP is preferred.

Nice-to-haves

• Expertise in specific areas, such as MPI/OMAR, APHIS, and recombinant processes would be considered a bonus.

Benefits

• Competitive medical, dental, and vision plans
• Mental health support
• Wellness incentives
• Telemedicine options
• Tuition reimbursement
• 401(k) retirement match
• Company-paid disability and life insurance
• Flexible spending accounts
• PTO beginning at 3 weeks' per year
• 9 paid holidays
• 40 hours of parental leave
• 8 hours of volunteer time off
• Opportunities to participate in charitable initiatives