Regulatory Executive
5 days ago
1. Domestic regulatory: Herbal extracts, Intermediates, Finished products
a. AYUSH : Documentation for licensing, 3 P audits, P2P liaising for all units as per Schedule T.
b. FSSAI: Documentation for 6 months mandatory testing, annual report submission (Form D1), hands on experience in handling FoSCos and other portals.
c. DRUG: Documentation for licensing, 3P audits, P2P liaising as per Schedule M.
d. Documentation of legal metrology and biodiversity related submissions.
2. Export regulatory: Herbal extracts, Intermediates, Finished products
a. Technical documentation for the group across various geographies like EU, USA, UK, GCC, ASEAN etc with hands on experience on handling online portals.
b. Technical preparation and documentation of Product Data sheet, Allergen Declaration, Certificate of Composition, Process Flow Chart and Safety Data Sheets.
c. Handling of IUCLD and REACH registrations for Europe.
d. Effective handling of queries with documentation.
e. Preparation and documentation of Drug master files (DMF) for effective dossier submissions as per ICH guidelines. Handling of CTD, A-CTD dossiers.
f. Documentation of Animal health product registration across various geographies.
g. Effective certification management: HALAL (MUI/IFANCA), ISO, FSSC, HACCP etc.
h. Assisting in units and warehouse audits for compliance.
The candidate should be reliable, adaptable, and self-motivated, with strong communication and teamwork skills. They should demonstrate integrity, professionalism, and a positive attitude, while being detail-oriented and able to manage time, cross functions and priorities effectively.
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