Regulatory Affairs Manager

Job Description

Job Purpose: Ensuring compliance with regulatory requirements and facilitating the approval and registration of products. Direct the preparation and submission of regulatory agency applications, reports, or correspondence. Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards. Reporting to: Individual Contributor role reporting to MD. Job Responsibilities Regulatory Compliance Management Understanding Regulations: Develop a thorough understanding of local, national, and international regulations related to bio-products and microbial inputs in agriculture. New GRs - Keep an eye on new Govt GRs and implement in current and upcoming registrations. Compliance Assessment: Review current practices and products to ensure they comply with relevant regulatory standards and requirements. Product Registration and Approval Preparation of Documentation: Prepare and review necessary documentation for the registration of microbial products, including technical data, efficacy studies, safety data, and labeling. Submission Process: Submit product registration applications to relevant regulatory authorities and manage the submission process, including responding to queries and requests for additional information. Regulatory Strategy: Develop and implement strategies for obtaining and maintaining regulatory approvals. Regulatory Reporting Periodic Reporting: Prepare and submit periodic reports as required by regulatory bodies, including post-market surveillance reports and updates on product performance and safety. Incident Management: Manage and report adverse events or incidents related to the use of bio-products. Regulatory Strategy and Planning Strategic Guidance: Provide strategic guidance on regulatory pathways and requirements for new product development and market entry. Regulatory Changes: Monitor and analyze changes in regulations and advise on their implications for the company's products and practices. Training and Development Knowledge Sharing: Keep the team updated on regulatory trends, changes, and best practices. Communication and Liaison Regulatory Liaison: Serve as the primary point of contact between client and regulatory authorities. Stakeholder Communication: Communicate regulatory requirements and updates to internal stakeholders, ensuring alignment and compliance across departments. Documentation and Record-Keeping Compliance Documentation: Maintain accurate and up-to-date records of all regulatory submissions, approvals, and communications. Audit Preparation: Prepare for and support internal and external audits related to regulatory compliance. Risk Management Compliance Risks: Identify potential compliance risks and develop mitigation strategies. Regulatory Challenges: Address and resolve regulatory challenges and issues as they arise. Product Lifecycle Management Ongoing Compliance: Ensure ongoing compliance throughout the product lifecycle, including post-market activities and modifications to products or processes. Re-registration: Manage re-registration processes and updates as required. Deliverables Regulatory Compliance Reports Periodic updates and reports on compliance status. Product Registration Documents – Completed applications and supporting documentation. Training Materials – Training programs and materials for staff education. Incident Reports – Documentation of adverse events and responses to regulatory authorities. Objectives Compliance of Regulatory Affairs - Scope of Work a. Visits to CIB & FCO for attaining licenses and registration for various states of India including godown licenses b. Registration of new activities, selling places and products. c. Export registration for current activities. d. Import sale and manufacturing activities. Responsibilities in details: Visit to CIB and Krishi Bhawan for liaisoning for biopesticide and bio stimulant registration. Visit to Universities for bio-efficiency trials liasoning. 3. Visit for tox studies liasoning. and prioritizing tasks to ensure regulatory compliance within set deadlines. Continuous Regulatory Monitoring: Keen on staying updated on regulatory changes and advancements in the fertilizer/pesticide industry. Proficient understanding of local and national regulations Obtain manufacturing licenses for pesticides, multi-micronutrients, fertilizers, Biofertilizer, Bio stimulant &import product license. Secure permissions for pesticides and fertilizer sales across states. • Coordination with state manager for licensing etc. Obtain bio-stimulant registrations (G2) including provisional registration(G3) and full registration at the central level. Coordination University for Product trail and insure to get the report in time Coordination to get product testing from NABL laboratory. Coordinate with the Consultant for CIB. to ensure compliance with regulatory requirements. Maintain accurate regulatory documentation and records. Liaise with internal teams for efficient coordination. Ensure labels comply with Fertilizer and Metrology Act standards. Coordination with MPCB, Factory Act to get permission and CGWA Insures the MPCB, Factory Act and CGWA compliance and annual reports and maintain records. EPR registration and compliance. To coordinate with the internal team to gather documentation required for tenders. Qualifications & Background: MSC IN entomology or plant pathology Or agrochemicals with 8-10 years’ experience. PHD is an added advantage. OR BSc or MSc Agri with 10-12 years’ experience & 7+ years handling regulatory affairs. A strong understanding of biology, microbiology, entomology, and toxicology related to biopesticides. Advanced degree in microbiology, biotechnology, or a related field Specialization in managing domestic regulatory affairs related to Fertilizer Control Order (FCO), Central Insecticides Board (CIB). And Factory related permission. Proficient Regulatory Understanding: Familiarity with both local and national regulations governing the field. Strong Communication Abilities: Capable of effectively communicating with regulatory agencies, internal teams, and external partners. Effective Regulatory Project Management: Skilled in coordinating cross-functional teams, establishing timelines.