Senior Regulatory Affairs Manager

SENIOR MANAGER REGULATORY AFFAIRS (Domestic & Exports)

Company: Zeon Lifesciences Ltd.
Location: Sector 65, Noida, Uttar Pradesh
Department: Regulatory Affairs
Reports To: Senior Vice President
Team: Domestic Regulatory Affairs & Export Regulatory Affairs

About Zeon Lifesciences

Established in 1987, Zeon Lifesciences is a leading end-to-end research-driven manufacturing partner for nutraceutical, Ayurvedic, herbal, immunity booster, phytopharma, medical nutrition, sports nutrition and health & wellness products. The company offers comprehensive manufacturing and product development solutions with a strong focus on research, quality and regulatory compliance.

Job Purpose

We are looking for an experienced and dynamic Senior Manager Regulatory Affairs to lead the Domestic and Export Regulatory Affairs functions. The incumbent will be responsible for ensuring end-to-end regulatory compliance, managing product registrations and licensing, overseeing regulatory documentation, coordinating with domestic and international regulatory authorities, and leading a team of regulatory professionals.

The role requires strong expertise in Indian regulatory frameworks, particularly FSSAI, AYUSH and Legal Metrology, along with experience in international product registrations, export documentation and country-specific regulatory requirements.

Key Responsibilities

1. Domestic Regulatory Affairs

• Lead end-to-end regulatory compliance for nutraceuticals, health supplements, proprietary foods, FSDU, FSMP and Ayurvedic proprietary medicines.
• Oversee product approvals, new product registrations, license renewals, modifications and Ayurvedic loan licensing.
• Review and approve product labels, artworks, claims, declarations and supporting regulatory documents.
• Ensure compliance with applicable FSSAI, AYUSH and Legal Metrology regulations.
• Liaise with regulatory authorities and manage regulatory queries, inspections and compliance-related matters.
• Support the Legal team in preparing responses to notices issued by FDA and AYUSH departments.
• Monitor changes in domestic regulations and drive timely implementation across relevant functions.
• Maintain regulatory trackers, compliance dashboards and documentation for all products.

2. Export Regulatory Affairs

• Lead product registrations, renewals and regulatory approvals for international markets.
• Manage the preparation, review and maintenance of technical dossiers, CMC documentation and country-specific regulatory submissions.
• Ensure the availability of export-related certificates and declarations, including MSDS, FSC, Pork-Free/TSE-BSE-Free declarations and Non-DG documents, as applicable.
• Coordinate with external agencies and certification bodies, including SGS and relevant international authorities.
• Manage country-specific regulatory requirements for markets such as Kenya, Sri Lanka, Vietnam, Myanmar, Cambodia and other export destinations.
• Work closely with Business Development and R&D teams on country-specific formulations, product claims, labelling, artwork, certifications and documentation.
• Track registration timelines, regulatory fees, sample requirements, approvals and license renewals.
• Ensure regulatory documentation remains updated throughout the product lifecycle, from registration to commercial supply.

3. Team Leadership & Development

• Lead, mentor and develop the Domestic and Export Regulatory Affairs teams.
• Allocate responsibilities, establish clear performance expectations and monitor deliverables.
• Review team performance, productivity, timelines and compliance outcomes.
• Develop SOPs, internal processes and standardised documentation practices.
• Conduct training sessions on regulatory updates, compliance requirements and industry best practices.
• Foster cross-functional collaboration, accountability and continuous improvement within the team.

4. Cross-Functional Coordination & Process Excellence

• Collaborate with R&D, QA/QC, Legal, Production, Business Development and other relevant departments to ensure regulatory readiness for new and existing products.
• Establish effective systems for tracking registrations, renewals, certificates, submissions and regulatory deadlines.
• Identify potential compliance risks and implement preventive and corrective actions.
• Provide regulatory guidance during product development, artwork finalisation and market expansion.
• Support management with regulatory status reports, risk assessments and updates on critical regulatory matters.

Required Qualifications & Experience

• Postgraduate qualification in a relevant discipline.
• Extensive experience in Regulatory Affairs within nutraceuticals, pharmaceuticals, Ayurvedic products, food supplements or related industries.
• Strong working knowledge of FSSAI, AYUSH and Legal Metrology regulations.
• Demonstrated experience in domestic regulatory compliance and international export registrations.
• Experience in managing regulatory documentation, licensing, certifications and interactions with regulatory authorities.
• Proven ability to lead teams and manage multiple regulatory projects simultaneously.
• Experience with international markets and country-specific regulatory requirements will be an advantage.

Key Skills & Competencies

• Domestic and Export Regulatory Affairs
• FSSAI, AYUSH and Legal Metrology Compliance
• Product Registration, Licensing and Renewals
• International Regulatory Submissions and Technical Dossiers
• Export Documentation and Certifications
• Regulatory Audits, Inspections and Liaison
• Labelling, Artwork and Claims Review
• Team Leadership and Stakeholder Management
• SOP Development and Process Improvement
• Project Management, Analytical Thinking and Problem-Solving
• Strong Communication and Documentation Skills

Note: The role requires a hands-on regulatory leader who can manage both domestic and export portfolios while building a structured, proactive and compliance-driven regulatory function.