Regulatory Compliance Specialist
3 days ago
At Zeon Lifesciences Ltd, we're seeking an exceptional Regulatory Compliance Specialist to lead our regulatory operations in the domestic market.
About the Role:
The successful candidate will be responsible for ensuring strict compliance with FSSAI and AYUSH formulation guidelines for our Proprietary Foods, Nutraceuticals, Health Supplements, Food for Special Dietary Users (FSDU), Food for Special Medical Purposes (FSMP), and Ayurvedic Proprietary Medicines. This includes managing compliance for new and existing products, overseeing the preparation and submission of relevant documents to regulatory authorities, and liaising with FSSAI and AYUSH authorities to strategize pre-submissions and address compliance test requirements.
Key Responsibilities:
- Supervise the timely preparation, review, and submission of documentation to regulatory authorities, ensuring compliance with 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 FSSAI and AYUSH authorities to 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 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. The estimated salary for this position is ₹12,00,000 - ₹18,00,000 per annum.
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