What are the responsibilities and job description for the Regulatory Affairs Manager (St Louis Park, MN) position at CEDENT?
Client is seeking a Regulatory Affairs Manager who will be an integral part of the Global Regulatory Policy & Registration Team. Reporting to the Director, Regulatory Science and Operations, this role will be responsible for ensuring leadership in regulatory agency and industry engagement in the US. The ideal candidate has experience working in the agricultural-product regulated environment. Occasional travel will be required for external engagements, team/company meetings, and conferences.
Responsibilities:
Responsibilities:
- Enable the commercialization of Client’s products by ensuring regulatory clearance with the appropriate regulatory authorities in the US
- Develop, submit, and monitor regulatory documents to ensure the achievement of key deliverables, such as USDA LNJ and LNPR letters, AIR determinations, and permit issuances as needed
- Develop and execute on strategic agency engagements on a regular basis
- A thought-leader in industry engagements and committees aimed at influencing regulatory bodies
- Keep abreast of global policies and guidelines as they relate to the regulatory policies of microbial biofertilizer products around the world and communicate potential changes to the Global Regulatory Policy & Registration team and other internal stakeholders.
- Liaise with Regulatory Science, Product Biosafety, and other functions to ensure product regulatory requirements are appropriately met in a timely manner
- BS, preferably in molecular biology, microbiology, or other relevant subjects
- 8 years of relevant experience with scientific and regulatory affairs in the ag input industry; specific expertise with microbial biofertilizers is a plus
- Knowledge of international regulations of agricultural products in other countries outside the US is a plus
- Project management experience is a plus
- Self-driven and able to manage multiple and changing priorities
- Strategic thinker with an exceptional attention to detail
- Strong interpersonal, written, and oral communication skills
- Available for up to 20% travel required for team, company, agency, and industry meetings
