Regulatory Affairs Domestic

CliniLaunch Research Institute; Mumbai; On-site; INR 900,000 - 1,300,000; Full time

Job summary

CliniLaunch Research Institute in Mumbai invites applications for Sr. Executive / Asst. Manager / Deputy Manager - Regulatory Affairs (Domestic). The role drives local regulatory functions, licensing, and compliance across the product lifecycle.

You will coordinate with FDA, DCGI, and FSSAI portals, prepare dossiers, ensure licenses, and support pharmacovigilance activities in headquarters and branches nationwide.

Qualifications

• M. Pharm degree required; experience preferred.
• Drive local regulatory functions, licensing, and compliance.
• Knowledge of Drugs & Cosmetics Act and schedules.
• Proficient with regulatory portals (FDA, Sugam, NSWS, FSSAI).
• Ability to coordinate technical documents and renew licenses.

Responsibilities

• Prepare registration dossiers to secure certificates and licenses from local FDA, DCGI, and FSSAI.
• Utilize online portals including FDA, Sugam, NSWS, and FSSAI (FOSCOS).
• Confirm product formula and label acceptability and ensure licenses are secured prior to product release.
• Coordinate with QC and R&D for dossiers (batch records, specs, analytical methods, validation, stability).
• Ensure timely renewal of drug and food licenses nationwide.
• Handle online applications for new drugs, SND, Test Licenses, Dual NOC, and Export NOC; maintain archival records.
• Monitor regulatory updates and respond to queries from authorities.

Skills

Regulatory affairs

Pharmacovigilance

Dossiers prep

Documentation

Communication

Education

M. Pharm

Tools

FDA portal

Sugam

NSWS

FSSAI (FOSCOS)

Job description

Hiring Alert: Regulatory Affairs (Domestic) - Sr. Executive / Asst. Manager / Deputy Manager

Qualification: M. Pharm (Experience preferred)

We are currently looking for an experienced professional to join our team as a Sr. Executive / Asst. Manager / Deputy Manager - Regulatory Affairs (Domestic) based in Andheri, Mumbai.

This role involves driving local regulatory functions, licensing, statutory compliance, and pharmacovigilance activities.

Key Responsibilities:

Local Regulatory Function & Licensing:

• Prepare registration dossiers to secure certificates and licenses from local FDA, DCGI, and FSSAI.
• Utilize online portals proficiently, including FDA, Sugam, NSWS, and FSSAI (FOSCOS), with a strong understanding of the Drugs & Cosmetics Act, Schedules (Sch Y, M, NDCT 2019, etc.).
• Confirm product formula and label acceptability and ensure licenses are secured prior to product release.
• Coordinate with QC and R&D departments for technical documents (batch records, specifications, analytical methods, validation reports, stability data) for dossiers.
• Ensure timely renewal of drug and food licenses for the head office and branch offices nationwide.
• Handle online applications for new drugs, SND, Test Licenses, Dual NOC, and Export NOC, while maintaining archival records of all regulatory permissions.
• Monitor regulatory updates and prepare responses to legal and technical queries raised by authorities.

Compliance of Packaging Modules:

• Formulate and implement statutory requirements for product artworks (labels, cartons, package inserts, PILs).
• Review packaging material artworks and draft package inserts as per New Drugs and Clinical Trials Rules (NDCT) 2019.
• Drive high-quality medical writing through planning and coordination of literature research.
• Draft and review PSURs focusing on medical aspects and product safety sections, along with Risk Management Plans.
• Assess the risk-benefit profile of products, identify gaps in aggregate documents, and conduct scientific reviews of aggregate reports/ICSRs produced by PV associates.