What are the responsibilities and job description for the Global Regulatory Affairs Manager position at Katalyst CRO?
Responsibilities
- The Regulatory Affairs Team is responsible for obtaining and maintaining regulatory approvals for Certos Biologicals line of biopesticides, bio stimulants, and bio nutrition products for agricultural applications
- This team works in partnership with Field Development, Marketing, Sales, Supply Chain, and other functions inside and outside the company to support our expanding global biological products business
- The Regulatory Affairs Team secures product approvals in the United States (including the individual States and territories), other NAFTA countries (Canada and Mexico), as well as the rest of the world (Europe, Africa, Middle East, Asia-Pacific, and Latin America)
- In this role you will be responsible for the Asia Pacific, Middle East and Africa portfolio and oversee the regulatory compliance of pesticide products throughout their lifecycle, ensuring all necessary registrations, submissions, and documentation adhere to local and international pesticide regulations, while collaborating with cross-functional teams to navigate complex regulatory landscapes and strategically manage product approvals and market access
- The Global Regulatory Affairs Manager will work closely with the Regulatory Affairs Team and Certis Biologicals commercial business-leaders to develop and align regulatory strategies and plans to ensure registrations are obtained and maintained to meet business objectives and timelines and executes accordingly
- This role will be widely viewed as someone who personifies our core values, is committed to them, and leans on them when making decisions
- Demonstrates a track record of high integrity - doing the right thing, owning mistakes, conducting oneself honestly
- Values, communicates, and interacts with others with high levels of transparency and respect
- Collaborates well across functions; creates an inspiring and collegial work environment
- Is optimistic, innovative and solution oriented
- Provide global regulatory leadership for the Active Ingredients/Products of your assigned portfolio and territories
- Plan, develop and execute robust submissions with high quality regulatory documents that ensure timely approval of product registrations in line with Marketing/Sales launch plans and Supply Chain based on the framework for territory and country authorities
- Lead projects with minimal guidance to ensure deadlines and standards are met
- Coordinate projects with external consultants as assigned and when necessary
- Provide foresight, evaluation, and thorough extensive expert knowledge of biopesticides regulatory affairs requirements and practices, analysis of current regulatory landscapes of biological products and potential future threats critical to the assigned active ingredients and/or end use products in assigned territories / countries
- Create processes to ensure tracking of the submissions and registrations, to communicate status, progress, and approvals to internal and external stakeholders, and increase efficiencies during the preparation of the submissions
- Provide partnership to the business with respect to registration strategies for new and existing products ensuring that Certis Biologicals products comply with the regulations
- Maintain knowledge of evolving and changing regulatory policies and procedures in the biological products space to ensure compliance; assist in disseminating regulations and guidelines with appropriate interpretation in context of assigned territories
- Develop and write clear arguments, explanations, and rationales for product registrations submissions and for responses to authorities
- Leverage the global regulatory team expertise
- Establish points of contact and build positive relationships with regulatory lead authorities and business partners
- Lead legalization and apostille processes as it pertains to international registrations.
- Bachelor's Degree with emphasis in chemistry, biology, agriculture, biotechnology, or related sciences.
- Five (5) or more years' experience in one or more of these regions dealing directly with Asia Pacific, Middle East and Africa with international regulatory Authorities and US Federal and State pesticide lead regulatory agencies.
- Experience in regulatory affairs of biofertilizers, biostimulants, bio-inoculants.
- Knowledge of Asia Pacific, Middle East, and Africa Authorities processes, international regulatory and FIFRA and 40 CFR Part 150-189 registrationrequirements.
- Demonstrate ability to communicate effectively (both written and oral) including strong interpersonal and facilitation skills to deal effectively and tactfully with people at all levels of management, with the ability to secure action from staff and management in a matrix organization.
- Demonstrate results orientated with the ability to think strategically while paying close attention to details.
- Strong track record of consistently meeting milestones and commitments.
