Assistant Manager - Regulatory Affairs (Pharma)

Role & responsibilities

The Assistant Manager Regulatory Affairs will manage regulatory activities related to the manufacturing and global supply of pharmaceutical excipients, ensuring compliance with Indian regulations (Schedule M, Drugs & Cosmetics Act) and support for international registrations and customer requirements. The role also includes support for compliance with Food Regulations.

Key Responsibilities:

• Regulatory Affairs India

- Prepare and submit applications for Drug Manufacturing Licenses, site approvals, and product-related permissions to State FDA/CDSCO

- Ensure full compliance with Schedule M (GMP) requirements for excipient manufacturing

- Handle site master files, SOPs, validation documentation, and ensure audit readiness for Indian regulatory inspections

- Coordinate with QA/QC, Production, R&D, Engineering, and SCM to ensure complete and accurate documentation for regulatory needs

- Liaise with regulatory authorities (State FDA, CDSCO) for approvals, renewals, inspections, and responses

- Maintain up-to-date records and documentation for regulatory compliances

- Assist in preparation and review of product labels, artworks, and promotional materials as per regulatory norms

- Monitor regulatory updates (e.g., CDSCO, IP) and coordinate internal implementation

- Support customer audits and due diligence for regulatory compliance in domestic markets

• Export Support & International Regulatory

- Coordinate with Pharmexcil, CDSCO, and State FDA for issuance and renewal of COPP, FSC, Written Confirmations, and product registrations

- Provide regulatory documentation to support customer registrations in various countries (technical data, GMP certificates, COA, MSDS, etc.)

- Ensure compliance with international pharmacopeias (USP/NF, BP, Ph. Eur.)

- Support customer audits and due diligence for regulatory compliance in export markets

• Food Regulatory Compliance Support

- Provide support for ensuring compliance with FSSAI and related food regulations

• Industry Representation

- Represent the company in industry bodies for policy updates and industry consultations

- Participate in technical committees, regulatory workshops, and forums to stay aligned with evolving regulations and standards

- Engage in dialogue with regulatory agencies and industry peers to advocate for excipient-related concerns

Key Skills & Competencies:

- In-depth knowledge of Indian regulations, especially Schedule M, Drugs & Cosmetics Act & Rules

- Familiarity with CDSCO portals (SUGAM), State FDA procedures, and GMP guidelines

- Exposure to export documentation and regulatory requirements for excipient registration in global markets

- Good understanding of IPEC guidelines, customer compliance expectations, and product stewardship

- Strong documentation and communication skills for handling regulatory submissions and external audits