Key responsibilities

Product registrations

- Work out the correct regulatory category and approval route for each imported product (drug, OTC, cosmetic, food supplement, special medical food, ayurvedic/herbal, medical device).

- Obtain drug import registrations and import licences from CDSCO (Drugs Controller General of India), including Registration Certificates for overseas manufacturers.

- Register imported cosmetics with CDSCO under the Cosmetics Rules.

- Obtain FSSAI approvals for imported foods, nutraceuticals and special medical purpose foods, including product approvals, the importer licence and import clearance.

- Handle other approvals as needed: State FDA licences (wholesale/storage), AYUSH, Legal Metrology (labelling and packaged commodity registration), BIS and the IEC.

- Keep a registration tracker for every product: status, renewal dates, and conditions of approval.

Agency liaison

- Be Oceanic's single point of contact with CDSCO, FSSAI, State FDA, port offices and other agencies.

- Follow up applications personally, attend hearings and meetings, and respond to queries and deficiency letters quickly.





- Support customs clearance at ports when regulatory documents are questioned.

Technical work

- Prepare and review dossiers: product formulas, specifications, certificates of analysis, stability data, free sale certificates, GMP certificates and power of attorney from overseas makers.

- Translate overseas manufacturers' technical documents into the format Indian regulators need, working closely with our Japan office and the suppliers.

- Review and approve Indian labels and pack inserts for regulatory compliance before printing.

- Check product ingredients against Indian rules (banned or restricted ingredients, permitted additives and claims)

Qualifications and experience

- B.Pharm / M.Pharm, or M.Sc in Food Technology, Chemistry or a related science. A regulatory affairs diploma is a plus.

- At least 10 years of hands-on regulatory work, with a proven record of import registrations that were approved.

- Has personally filed and obtained approvals with CDSCO (drug and/or cosmetic import registration) and FSSAI (product approval and import clearance).

📌 Regulatory Affairs Manager Import Registrations (India) (Mumbai)
🏢 Reputed Organization
📍 Mumbai