Regulatory Affairs Manager

Key Responsibilities

• Full responsibility for registration, renewal, and label expansion of crop protection products, including biologicals, microbials, biostimulants, and chemical formulations.
• Develop and lead regulatory strategies for both the existing portfolio and products under development, aligned with business goals and target markets.
• Prepare, manage, and submit regulatory dossiers, including safety, efficacy, quality, manufacturing, and CMC data.
• Lead regulatory and field efficacy trials in collaboration with R&D teams, external consultants, CROs, and contractors, locally and internationally.
• Serve as the primary interface with regulatory authorities in Israel and abroad, including correspondence management, responses to questions, and handling objections or data gaps.
• Continuously monitor regulatory developments and assess their impact on the company’s products and pipeline.
• Provide regulatory leadership throughout the product development lifecycle, from concept through commercialization (Regulatory by Design).
• Deliver regulatory guidance to marketing and sales teams, including claims substantiation, labeling, and marketing materials.
• Manage external consultants, service providers, and regulatory budgets.
• Identify, assess, and mitigate regulatory risks, and lead corrective and preventive actions.
• Build, lead, and manage the regulatory team, including staff and consultants located internationally.

Qualifications and Experience

• Advanced academic degree (MSc or PhD) in Plant Sciences, Agronomy, Biology, Biotechnology, Chemistry, or a related discipline.
• Proven experience in crop protection regulatory affairs, with a strong emphasis on biological products; over 10 years of experience is a significant advantage.
• Experience with international regulatory frameworks (EU, EPA, OECD) is an advantage.
• Solid knowledge of microbial products, plant extracts, and biological crop protection solutions.
• Hands-on experience managing field trials and efficacy data, including collaboration with international laboratories and consultants.
• Excellent command of English, both written and spoken.
• Strong ability to work independently, take ownership, and lead the regulatory function within an entrepreneurial, fast-paced environment.
• Demonstrated experience in managing teams, including remote and international teams.