The Sr. Associate – Regulatory Affairs at DDReg Pharma Pvt Ltd will support regulatory strategy, submissions, and compliance for health supplements and nutraceuticals in India. The role demands strong hands-on expertise in FSSAI regulations, filings, and regulator interactions, along with the ability to manage end-to-end regulatory processes for clients.
Job Descriptions
Manage preparation, compilation, review, and submission of dossiers for FSSAI product approvals, licenses, and registrations.
Handle FoSCoS portal activities including new applications, renewals, and modifications.
Respond to regulatory queries, deficiencies, and notices from FSSAI authorities.
Ensure compliance with FSSAI regulations including Nutraceuticals Regulations and Labelling & Packaging requirements.
Provide regulatory guidance to internal teams and clients on product classification, claims, and ingredient compliance.
Build and maintain strong liaison with FSSAI officials and industry stakeholders.
Support regulatory strategy and intelligence activities for nutraceutical products.
Maintain documentation and support audits and inspections.
Knowledge, Skills and Abilities
Strong knowledge of FSSAI regulations and compliance systems.
Hands-on experience with FoSCoS filings and documentation.
Proven ability to interface with regulatory authorities and manage filings independently.
Excellent communication, attention to detail, and stakeholder management skills.
Qualification and Experience
Bachelor’s or Master’s degree in Food Technology, Pharmacy, Life Sciences, Nutrition or related field.
3–6 years’ experience in regulatory affairs within nutraceuticals/health supplements/food/pharma sector.
Mandatory experience in FSSAI filings and regulatory processes.