Senior Executive - Regulatory Affairs

Have good exp in Biologicals, Biosimilars, Injectables, Vaccines and Medical Devices

Perform high-quality CMC review of technical documentation i.e. CTD Modules, Medical Data Packages, SmPCs, PIs, PILs, and Labelling documents, for filings with HA in emerging markets.

Attend Pre-Submission meetings with the HA and prepare post-meeting package/minutes for internal, client, and HA records.

Assist in the preparation of high-quality dossiers for various markets.

Adequacy Review and Gap Analysis of Technical Documentation for Non-CTD/CTD/ACTD dossier.

Closure of comments with the internal and client teams & review of additional incoming data.

Review and Compilation of Dossier.

Review of shortcomings/ deficiencies/ supplements received from HA and coordinate with internal and client teams for an effective response.

Proper record keeping, complying with internal and client SOPs, while ensuring data security compliance.

Collaborate with internal and external clients for various functional/transition activities, including translation of documents, before and post submission to HA.

Prepare customized reports, to suit the client's objectives. Provide regulatory intel, knowledge, and market knowledge to ensure the success of the client’s application.

Supporting and enabling effective and efficient communication internally and externally to ensure operational excellence and client satisfaction.

Be meticulous, observant, and thorough while performing any activity and in communication with internal teams and clients.

Demonstrate subject matter and area expertise and high-level knowledge of country regulations and guidelines as updated from time to time through different teams.

Job Types: Full-time, Permanent

Pay: ₹30,000.00 - ₹35,000.00 per month

Benefits:

• Flexible schedule

Experience:

• Injectables, Medical Devices and Biologicals & Biosimilars : 2 years (Required)

Location:

• Dehradun, Uttarakhand (Required)

Work Location: Remote