Head - Regulatory Affairs

Key Responsibilities:

Lead regulatory affairs for biopesticides, biofertilizers, biostimulants, soil health products and other agricultural inputs.

Manage registrations and compliance under CIB&RC / Insecticides Act and FCO.

Develop and execute regulatory strategies for existing and new products in India and export markets.

Lead preparation, review and submission of regulatory dossiers, applications and supporting documents.

Coordinate regulatory studies including bioefficacy, toxicity, ecotoxicology, stability, strain identification and characterization.

Manage product registrations, renewals, amendments, endorsements and post-registration requirements.

Ensure product labels, claims, technical literature and marketing materials comply with approved registrations and applicable regulations.

Monitor regulatory changes, Gazette Notifications, guidelines and government requirements and assess their impact on the business.

Handle regulatory queries, deficiencies, inspections, notices, sample failures, complaints and other enforcement matters.

Liaise with CIB&RC, State Agriculture Departments, licensing authorities, laboratories, research institutions and other regulatory bodies.

Lead regulatory registrations in priority international/export markets and coordinate with overseas regulatory consultants and representatives.

Ensure compliance related to microbial products, including biodiversity, biosafety, plant quarantine, Legal Metrology and other applicable statutory requirements.

Provide regulatory inputs to R&D, Quality, Manufacturing, Product Management, Sales and Marketing teams.

Review and approve regulatory aspects of labels, leaflets, brand names, marketing collateral and product claims.

Build, guide and develop the Regulatory Affairs team and establish effective SOPs, systems and document controls.

Maintain regulatory databases, registration validity records, renewal calendars and regulatory commitments.

Manage regulatory budgets, consultants, government fees and study-related costs.

Conduct inspection-readiness reviews and internal regulatory compliance audits.

Report regulatory status, risks, compliance gaps and key regulatory KPIs to the Managing Director.

Work experience

Min.: 15 years

Preferred: 15+ years of relevant regulatory experience in Agri-inputs, preferably Agricultural Biologicals.

Department: Regulatory Affairs

Keywords

• CIB&RC Registration
• FCO Compliance
• Agricultural Biologicals
• Biofertilizer / Biopesticide / Biostimulant Registration
• Regulatory Dossier Preparation
• Product Registration & Renewals
• Regulatory Compliance
• Label & Claim Compliance
• Government Liaison
• Regulatory Studies
• Bioefficacy Trials
• Toxicity / Ecotoxicology Data
• Microbial Strain Documentation
• Export Registration
• Regulatory Risk Management
• Regulatory Audits
• SOP & Compliance Management
• Team Leadership
• Stakeholder Management

Basic / UG Qualification: Bachelor's degree in Agriculture, Biotechnology, Microbiology, Plant Pathology, Entomology, Chemistry or a related discipline.

PG Qualification: M.Sc. / Ph.D. in Agriculture, Agricultural Microbiology, Plant Pathology, Entomology, Biotechnology, Microbiology, Chemistry or a related discipline.

Reporting To Managing Director