Sr. Officer/Executive-Regulatory Affairs(Regulated Market)

Navlakha Management Services; Mumbai; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Navlakha Management Services is seeking a Sr. Officer/Executive Regulatory Affairs (US Market) in Kandivali, Mumbai. The role requires 3–6 years of Regulatory Affairs experience with a B.Pharm or M.Pharm degree.

You will manage regulatory submissions for the US market, coordinate with QA/QC/R&D and other functions, and ensure timely responses to agency queries. Responsibilities include preparing registration dossiers, handling eCTD submissions, post-approval variations, renewals, and maintaining

Qualifications

• 3–6 years of regulatory affairs experience.
• Experience in US market submissions and post-approval activities.
• Degree in Pharmacy (B.Pharm or M.Pharm).
• Knowledge of FDA guidelines and dossier preparation.

Responsibilities

• Handle regulatory submissions and post-approval activities for the US market.
• Prepare registration dossiers per regulatory guidelines.
• Submit GCC dossiers, variations, and query responses via eCTD software.
• Ensure timely agency query responses to expedite approvals.
• Prepare post-registration variations and oversee drug registration renewals.
• Review documents from QA/QC/R&D/Marketing before dossiers.
• Maintain regulatory database for the US market.
• Coordinate with cross-functional teams for document finalization.
• Obtain FDA-notary, chamber, apostille, and embassy legalization as needed.
• Dispatch hard copies and samples to evaluation countries.

Skills

Regulatory affairs

US market registration

Cross-functional coordination

Education

B.Pharm / M.Pharm

Tools

eCTD software

Job description

Job Title: Sr. Officer/Executive Regulatory Affairs (US Market)

Location: Kandivali, Mumbai

Department: Regulatory Affairs

Experience: 3-6 Years

Qualification: B.Pharm / M.Pharm

Industry: Pharmaceutical / Formulation

Job Description:

We are looking for an experienced Sr. Officer/Executive Regulatory Affairs (US Market) to handle regulatory submissions and post-approval activities for the US market.

Role & responsibilities

• Responsible for activities related to US/EU market.
• Prepare the registration dossiers as per regulatory guidelines.
• Submitting GCC dossiers, variations, and query responses through eCTD software.
• Ensure timely preparation of the agency's query responses to expedite approvals.
• Prepare and submit post-registration variations application, Involved in the renewal process of drug registration.
• Review technical documents on receipt from various departments before inclusion in various applications and dossiers.
• Maintenance of the regulatory database for the US market.
• Product Lifecycle Management .
• Discuss and coordinate with cross-functional teams like QA, QC, R&D, Analytical, marketing, manufacturing plant, administrative dept., etc. for finalization of documents and with API vendor for getting DMF, LOA, CEP, and other API-related documents .
• Responsible for getting the FDA-approved documents legalized such as Notary, Chamber, Apostille, Embassy, etc.
• Responsible for sending the hard copies of documents, samples, columns, impurities, placebo, etc. to respective countries of evaluation
• Being updated with relevant regulatory guidelines.