Regulatory Affairs Manager Import Registrations (India)

Reputed Organization; Mumbai; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Reputed Organization in Mumbai seeks an experienced Regulatory Affairs professional to manage import registrations for drugs, cosmetics, foods and medical devices. You will determine regulatory routes, prepare filings, and coordinate with overseas manufacturers.

You will serve as the single point of contact with CDSCO, FSSAI, and State FDA, oversee dossiers, translate technical documents, review labels, and ensure compliance across product registrations and approvals.

Qualifications

• B.Pharm / M.Pharm, or MSc in Food Technology, Chemistry or related science.
• At least 10 years hands-on regulatory work with import registrations.
• Has filed and obtained CDSCO and FSSAI approvals.

Responsibilities

• Determine regulatory category and approval route for imported products (drugs, cosmetics, foods).
• Obtain import registrations and licences from CDSCO, including certificates for overseas manufacturers.
• Register imported cosmetics with CDSCO under Cosmetics Rules.
• Obtain approvals from FSSAI for imported foods, nutraceuticals, and other products.
• Manage other approvals: State FDA licences, AYUSH, Legal Metrology, BIS, IEC.
• Keep a registration tracker with status, renewal dates, and conditions.

Skills

Regulatory affairs

Stakeholder liaison

Documentation

Attention to detail

Education

B.Pharm / M.Pharm

M.Sc in Food Technology or Chemistry

Regulatory affairs diploma (plus)

Tools

CDSCO/FDAs processes

Dossier preparation

Job description

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).