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

Location: Mumbai

Department: Regulatory Affairs

Experience: 3-6 Years

Qualification: B.Pharm / M.Pharm

Industry: Pharmaceutical / Formulation

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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.

📌 Sr. Officer/Executive-Regulatory Affairs(Regulated Market) (Mumbai)
🏢 Navlakha Management Services
📍 Mumbai