Regulatory Affairs Manager
NewLeaf Symbiotics (NLS), an agricultural biologicals company, has an immediate opening for a Regulatory Affairs Manager to join the team at NewLeaf’s headquarters located at the BRDG Park facility of the Donald Danforth Plant Science Center, in St. Louis, Missouri. We are seeking a professional with expertise in regulatory affairs and has a passion for sustainable agriculture and agricultural biological solutions. The position requires experience managing regulatory projects directly linked to product line expansion and strategic growth. Experience with US EPA/PMRA BPPD harmonized submissions and an understanding of Biochemical/PGR registrations are essential. Administrative understanding of state regulation of biostimulants, an interest in reshaping off-patent strategies, and experience with international regulatory work is preferred. NewLeaf offers a competitive salary and comprehensive benefits package including stock options and health coverage.
- Coordinate the domestic and international product registration process. Manage the development and archiving of standard operating procedures based on a working understanding of manufacturing processes.
- Review and revise existing product specifications as required for safety data sheets and standard regulatory documents. Identify and coordinate CRO studies required to support registrations.
- Integrate documentation for new products with NLS communication strategy based on current events and market trends.
- Apply global regulatory compliance knowledge to NLS products and their interaction with complimentary products.
- Act as liaison with US EPA, USDA/APHIS, PMRA/CIFA (Canada), Senasa (Argentina), Embrapa and MAPPA (Brazil), EU agencies, and other government regulatory bodies.
- Participate in industry groups such as: National Pest Management Association, Biological Products Industry Alliance, US Biostimulant Coalition, etc.
- Bachelor’s degree in regulatory science or related discipline with 3+ years’ experience, or recent MS or Ph.D graduate in a similar field. Experience in a global focused regulatory related role.
- Experience dealing with regulatory authorities and policymakers. Basic knowledge of crop protection industry: technical, commercial, farming techniques, crop specific issues, etc. Familiarity with risk assessment.
- Experience with the development of biologically-based products for the food, agrichemical or specialty chemical industry.
Please email a cover letter and CV/Resume with the Subject Line: Regulatory Affairs Manager, to firstname.lastname@example.org. References required upon request.