Job Description
Minimum Qualification & Experience:
• This is a full time, on site role for Regulatory Affairs Specialist, Nutrition/Nutraceuticals located in Hyderabad.
• Master’s Degree in Food Science/Nutrition or related disciplines and/or Master’s Degree in Pharmaceutical sciences
• Minimum 5-7 years of experience in Nutrition and/or Nutraceuticals Regulatory Affairs for India and other mature and/or emerging markets.
• Thorough knowledge of licensing, handling technical queries/deficiencies from regulatory authority (FSSAI), post preparation and submission of dossiers, non-specified food approvals and regulatory updates
• Experience in interaction with health authorities, regulatory influencers and key stakeholders in regulatory and government
• Experience of working in inter-cultural and cross functional teams is a must
• Experience in Pharmaceutical Regulatory affairs is a plus
Reporting: Head Regulatory, (Nutrition/Nutraceuticals).
Key Job Responsibilities:
Regulatory strategy / Dossiers submission, risk assessment and product life cycle management
• In depth understanding of regulatory framework and requirements in India and emerging countries/regions/markets (ROW, CIS, ASEAN)
• Ensure total regulatory compliance of products
• Ensure regulatory compliance for all category of products (Standardized foods, Proprietary foods, Food additives, Food Ingredients, Probiotics, FSDU, Health supplements, Nutraceuticals, etc) with respect to Food safety and standards Act, Food Safety and Standards & Legal Metrology Act, regulations and rules
• Project Management- Ensure product filings are executed as per agreed timelines in continuous collaboration with cross functional teams. Ability to analyse, organize, prioritize and manage multiple projects
• Effective interpretation and monitoring of Nutraceutical existing and upcoming regulatory guidance(s)
Stakeholder Management (Internal and external)
• Interact, contribute and collaborate with all the cross function teams (R&D, NPD, Sales and Marketing etc) to ensure compliance as well as risk assessment analysis of shortlisted or launched products
• Work closely with relevant stakeholders to obtain significant information as well as answer queries that may arise to ensure timely submissions to the relevant regulatory authority
• Support the maintenance of regulatory files to ensure prompt and accurate access to company regulatory information (concerning current, pending and future approvals and renewals)
• Ensure that all business and technical agreements are evaluated with respect to Regulatory Compliance
Critical Skills Required:
• Clear understanding and minimum 4-5 years of experience in obtaining, maintaining licenses in India (FSSAI- Licensing and Registration Regulation)
• Complete knowledge of dossier submission requirements and specifically should have 2-3 years of experience in filing Non-Specified Food applications in India
• Able to work with cross functional internal and external stakeholders
• Excellent written and oral communication skills
• Open to learning new ways of working
• This is a full time, on site role for Regulatory Affairs Specialist, Nutrition/Nutraceuticals located in Hyderabad.
• Master’s Degree in Food Science/Nutrition or related disciplines and/or Master’s Degree in Pharmaceutical sciences
• Minimum 5-7 years of experience in Nutrition and/or Nutraceuticals Regulatory Affairs for India and other mature and/or emerging markets.
• Thorough knowledge of licensing, handling technical queries/deficiencies from regulatory authority (FSSAI), post preparation and submission of dossiers, non-specified food approvals and regulatory updates
• Experience in interaction with health authorities, regulatory influencers and key stakeholders in regulatory and government
• Experience of working in inter-cultural and cross functional teams is a must
• Experience in Pharmaceutical Regulatory affairs is a plus
Reporting: Head Regulatory, (Nutrition/Nutraceuticals).
Key Job Responsibilities:
Regulatory strategy / Dossiers submission, risk assessment and product life cycle management
• In depth understanding of regulatory framework and requirements in India and emerging countries/regions/markets (ROW, CIS, ASEAN)
• Ensure total regulatory compliance of products
• Ensure regulatory compliance for all category of products (Standardized foods, Proprietary foods, Food additives, Food Ingredients, Probiotics, FSDU, Health supplements, Nutraceuticals, etc) with respect to Food safety and standards Act, Food Safety and Standards & Legal Metrology Act, regulations and rules
• Project Management- Ensure product filings are executed as per agreed timelines in continuous collaboration with cross functional teams. Ability to analyse, organize, prioritize and manage multiple projects
• Effective interpretation and monitoring of Nutraceutical existing and upcoming regulatory guidance(s)
Stakeholder Management (Internal and external)
• Interact, contribute and collaborate with all the cross function teams (R&D, NPD, Sales and Marketing etc) to ensure compliance as well as risk assessment analysis of shortlisted or launched products
• Work closely with relevant stakeholders to obtain significant information as well as answer queries that may arise to ensure timely submissions to the relevant regulatory authority
• Support the maintenance of regulatory files to ensure prompt and accurate access to company regulatory information (concerning current, pending and future approvals and renewals)
• Ensure that all business and technical agreements are evaluated with respect to Regulatory Compliance
Critical Skills Required:
• Clear understanding and minimum 4-5 years of experience in obtaining, maintaining licenses in India (FSSAI- Licensing and Registration Regulation)
• Complete knowledge of dossier submission requirements and specifically should have 2-3 years of experience in filing Non-Specified Food applications in India
• Able to work with cross functional internal and external stakeholders
• Excellent written and oral communication skills
• Open to learning new ways of working
💡 Quick Summary
Seeking a career-building opportunity? The Specialist Regulatory Affairs position is now open for candidates interested in the Lab Technician / Pharmacist Jobs sector. This role in Telengana offers a professional environment and growth potential.
Requirement Snapshot: Candidates should possess basic communication skills, a proactive attitude, and the ability to work in a team. Experience in Lab Technician / Pharmacist Jobs is a plus.
