Regulatory Affairs Manager

3 days ago

Noida, India Zeon Lifesciences Ltd Full time

The Regulatory Manager will be responsible for overseeing and ensuring that all food compliance mandates related to FSSAI and AYUSH formulation guidelines are strictly adhered to. This includes managing compliance for Zeon's domestic product range, which covers Proprietary Foods, Nutraceuticals, Health Supplements, Food for Special Dietary Users (FSDU), Food for Special Medical Purposes (FSMP), and Ayurvedic Proprietary Medicines. The role ensures smooth regulatory operations for both new and existing products in the domestic market.

Key Responsibilities:

Operational Excellence & Regulatory Compliance:

  • Supervise and ensure the timely preparation, review, and submission of relevant documents (e.g., artwork, labeling compliance, statements) to regulatory authorities for the issuance of new licenses or modification of existing licenses, as per FSSAI, Legal Metrology, and AYUSH regulations.
  • Manage the preparation and critical review of Ayurvedic Loan License and Product Approval Applications, ensuring all documentation complies with regulatory mandates before submission.
  • Liaise with regulatory authorities (FSSAI, AYUSH) to strategize pre-submissions, discuss potential regulatory pathways, and address compliance test requirements or follow-ups for submissions under review.
  • Monitor regulatory updates, guidelines, and amendments from authorities (FSSAI, Legal Metrology, AYUSH) and provide knowledge transfer to internal stakeholders via meetings, mailers, and other communication methods.
  • Assess the impact of regulatory changes on the business, propose solutions, and implement necessary changes to product formulations, artwork, and labeling to ensure compliance.
  • Coordinate with internal departments (R&D, QA/QC, BD, Legal, Production) and external stakeholders to ensure regulatory compliance, manage compliance deadlines, and resolve technical and non-technical queries.
  • Support the Legal team by providing technical input for responses to notices issued by FDA and AYUSH authorities.
  • Maintain records of all regulatory compliance deadlines and project updates, sharing them with management for review and action.

Team Management & Development:

  • Collaborate with HR/Training Coordinators to design and monitor training programs that ensure the team has the necessary skills to perform regulatory duties efficiently and in compliance with safety standards.
  • Communicate expectations clearly to the team, keep them informed on regulatory matters, and support their professional development.
  • Continuously update the team's knowledge with the latest certifications and developments in regulatory affairs.
  • Participate in industry meetings and forums (such as those hosted by CII) to stay informed on emerging trends, amendments, and regulations in food safety.

Candidate Profile:

  • In-depth understanding of FSSAI, ICMR-RDA, AYUSH, and Legal Metrology guidelines and compliance requirements.
  • Significant experience in Regulatory Affairs, particularly in the domestic market for Food, Nutritional, and Ayurvedic products.
  • A Masters degree in Pharmacy (M. Pharm) or Food Technology is preferred.
  • Strong written and verbal communication skills, with a focus on precise and effective regulatory documentation.
  • Detail-oriented with a research-focused mindset.
  • Proven ability to manage and develop teams effectively.

This role requires a proactive individual with a passion for regulatory compliance, strong leadership skills, and a commitment to staying ahead in the ever-evolving landscape of food safety regulations.

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