Website:
chw.co.in
Job details:
Job Description: Regulatory Affairs Manager – Nutraceuticals
Position: Regulatory Affairs Manager – Nutraceuticals
Experience: 10–15 Years
Location: Noida 73, Uttar Pradesh
Industry: Nutraceuticals / Food Supplements / Healthcare Manufacturing
Employment Type: Full-Time
Share your CV at rajneet@chw.co.in
ONLY NOIDA,DELHI-NCR CANDIDATES CAN APPLY
Job Summary
We are looking for an experienced Regulatory Affairs Manager with extensive expertise in the nutraceutical industry. The ideal candidate should have in-depth knowledge of FSSAI regulations, product registration, label compliance, licensing, and the complete regulatory approval process for nutraceutical and health supplement products. The candidate will be responsible for ensuring that all products comply with applicable regulatory requirements while supporting new product development and market launches.
Key Responsibilities
- Manage the complete regulatory lifecycle of nutraceutical and health supplement products.
- Handle FSSAI product registration, licensing, approvals, amendments, renewals, and regulatory submissions.
- Ensure compliance with all applicable FSSAI, Food Safety & Standards Regulations, and other relevant Indian regulatory requirements.
- Review and approve product formulations, ingredient compliance, and health claims as per regulatory guidelines.
- Verify product labels, packaging artwork, nutritional information, and marketing materials for regulatory compliance.
- Coordinate with R&D, Quality Assurance, Production, Procurement, and Marketing teams during new product development and launches.
- Prepare and maintain technical dossiers, product documentation, specifications, Certificates of Analysis (COAs), stability data, and other regulatory records.
- Liaise with regulatory authorities, certification bodies, and consultants for approvals and compliance-related matters.
- Monitor changes in Indian regulatory requirements and implement necessary updates across the organization.
- Support audits, inspections, and regulatory assessments by maintaining complete and accurate documentation.
- Provide regulatory guidance for product import/export documentation whenever required.
- Develop and implement SOPs related to regulatory affairs and ensure adherence across departments.
- Train internal teams on regulatory requirements, labeling norms, and compliance standards.
- Identify regulatory risks and recommend appropriate mitigation strategies.
- Ensure timely regulatory approvals to support business objectives and product launches.
Required Qualifications
- Bachelor's or Master's degree in Pharmacy, Food Technology, Food Science, Biotechnology, Life Sciences, Nutrition, or a related field.
- Additional certification in Regulatory Affairs will be an added advantage.
Experience
- 10–15 years of relevant experience in Regulatory Affairs within the Nutraceutical, Food Supplement, Functional Foods, or Healthcare industry.
- Proven experience handling FSSAI product registration and regulatory compliance independently.
- Experience working with manufacturing facilities compliant with FSSAI, WHO-GMP, ISO, and HACCP standards is preferred.
Required Skills
- Strong expertise in FSSAI regulations, licensing, and product registration processes.
- Thorough understanding of Nutraceutical, Health Supplement, Food for Special Dietary Use (FSDU), and related regulatory frameworks.
- Excellent knowledge of ingredient compliance, product claims, and labeling regulations.
- Experience preparing and reviewing regulatory dossiers and technical documentation.
- Strong understanding of food safety and quality management systems.
- Excellent documentation, analytical, and problem-solving skills.
- Strong communication and stakeholder management abilities.
- Ability to manage multiple projects and regulatory timelines effectively.
- Proficiency in Microsoft Office (Word, Excel, PowerPoint).
Preferred Candidate Profile
- Self-driven, detail-oriented, and highly organized.
- Strong leadership and cross-functional coordination skills.
- Ability to work independently and take ownership of regulatory functions.
- Excellent decision-making and regulatory interpretation skills.
- Immediate joiners will be preferred.
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