Senior Regulatory Affairs Associate

Robert Half

  • Full Time

We are seeking a Senior Regulatory Affairs Associate based in Des Moines, Iowa. This role will involve overseeing regulatory support and compliance within the parameters set by various regulatory agencies such as USDA and FDA. The successful candidate will also be involved in new product development and managing controlled documents.

Responsibilities:

• Engage with government agencies and business partners on regulatory issues

• Provide required documentation to partners and international agencies for product registration

• Assist in the process of new product licensing

• Apply for and renew permits for receiving regulated materials and international product exportation

• Collaborate with various departments to plan, organize, conduct, and monitor clinical trials and testing

• Develop protocols and prepare final reports for clinical trials

• Review, update and draft new Standard Operating Procedures within the Regulatory Affairs Department

• Review and prepare outlines of production and special outlines

• Develop and revise ASR/Sampling Plans for raw materials, in-process products, and stability programs

• Prioritize Document Control submissions and lead the document review process for timely approvals

• Provide guidance to other departments on regulatory and in-house requirements for documenting incoming raw materials and approving new vendors

• Organize and maintain a system to track seed and cell records for easy tracing of final product lineage

• Conduct inspections and audits related to seed/cell tracing

• Stay current with applicable regulations

• Provide training for Regulatory staff

• Manage new product development initiatives

• Support Quality Assurance efforts.


Job Requirements

• Demonstrated ability to work with government agencies and programs

• Familiarity with product licensing procedures and regulations

• Excellent communication and interpersonal skills

•Prior experience adhering to strict compliance regulations

• Bachelor’s degree

• Ability to handle sensitive information with discretion and confidentiality

About Robert Half

Robert Half is the world’s first and largest specialized talent solutions firm that connects highly qualified job seekers to opportunities at great companies. We offer contract, temporary and permanent placement solutions for finance and accounting, technology, marketing and creative, legal, and administrative and customer support roles.

Robert Half works to put you in the best position to succeed. We provide access to top jobs, competitive compensation and benefits, and free online training. Stay on top of every opportunity – whenever you choose – even on the go. Download the Robert Half app and get 1-tap apply, notifications of AI-matched jobs, and much more.

All applicants applying for U.S. job openings must be legally authorized to work in the United States. Benefits are available to contract/temporary professionals, including medical, vision, dental, and life and disability insurance. Hired contract/temporary professionals are also eligible to enroll in our company 401(k) plan. Visit roberthalf.gobenefits.net for more information.

© 2024 Robert Half. Robert Half is not a law firm and does not provide legal representation. Robert Half project lawyers do not constitute a law firm among themselves. An Equal Opportunity Employer. M/F/Disability/Veterans. By clicking “Apply Now,” you’re agreeing to Robert Half’s Terms of Use.

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