Regulatory Affairs Manager

Role & responsibilities

JOB DESCRIPTION

Company: Kumar Organic Products Ltd.
Position: Regulatory Manager Technical
Department: Technical / Regulatory Affairs
Reporting To: Director – Works
Area of Responsibility: Regulatory Affairs and Interface with Marketing

Job Purpose

To lead and manage regulatory affairs, product registration, formulation development, and technical coordination activities across domestic and international markets, while ensuring compliance with applicable regulations and supporting business growth through strategic planning and cross-functional collaboration.

Key Responsibilities

• Manage regulatory affairs for products across industries such as Cosmetics, Personal Care, Home Care, and Paints.
• Identify regulatory requirements for new products in different countries and prepare strategic regulatory plans.
• Liaise with Plant QA and internal teams to obtain necessary regulatory approvals and ensure compliance.
• Prepare and submit applications for domestic and international registrations, including exports, FSSAI, drug, cosmetic, USFDA, REACH, and other global regulations.
• Coordinate with national and international regulatory bodies (e.g., US EPA, BPR, NDA, and other authorities) for certifications, approvals, and compliance updates.
• Prepare and submit regulatory dossiers as per domestic and international requirements.
• Ensure closure of customer complaints in coordination with QA and Sales, maintaining proper documentation and records.
• Support the Marketing team with technical data such as MSDS, technical bulletins, and product documentation.
• Prepare endorsement applications (e.g., Free Sale Certificates) for various products.
• Handle applications for Research Test & Trial (RTT) permits for product validation and approvals.
• Collaborate with research institutes, ICAR, and agricultural universities to conduct field trials and generate data for registrations.
• Develop technical literature for new and existing products and coordinate its dissemination across departments.
• Drive pre-registration product development activities including identification and in-house trials.
• Coordinate with R&D for formulation development and optimization.
• Lead development of new product blends, including stability studies, formulation, clinical studies, accelerated studies, prototype development, and dossier preparation.

Skills & Competencies

• Strong knowledge of global regulatory frameworks (USFDA, REACH, FSSAI, etc.)
• Expertise in dossier preparation and product registration processes
• Cross-functional coordination and stakeholder management
• Analytical thinking and strategic planning abilities
• Strong documentation and technical writing skills
• Problem-solving and decision-making capabilities
• Effective communication and liaison skills

Education & Experience

• Bachelor’s or Master’s degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or related field
• 8–12 years of experience in Regulatory Affairs, Technical Services, or Product Development
• Experience in handling international regulatory submissions is highly preferred

Key Performance Indicators (KPIs)

• Timely completion of product registrations and approvals
• Accuracy and compliance of regulatory submissions
• Effectiveness in coordination with regulatory authorities and internal teams
• Quality and completeness of technical documentation and dossiers
• Contribution to successful product development and commercialization
• Reduction in regulatory delays and non-compliance issues

Key Interfaces

• Internal: R&D, QA, Production, Sales & Marketing
• External: Regulatory Authorities, Certification Bodies, Research Institutes, Universities