Manager Regulatory Affairs

Thornton Tomasetti; Mumbai; On-site; INR 1,500,000 - 2,200,000; Full time

Job summary

Thornton Tomasetti in Mumbai, India, is seeking a Manager Regulatory Affairs to lead a team and guide regulatory strategy for device, biologic or drug products. The role covers submission development, regulatory liaison, and lifecycle management across cross-functional teams.

The position focuses on mentoring, coaching and coordination within a fast-paced regulatory environment, ensuring timely approvals and effective regulatory oversight throughout product lifecycle.

Qualifications

• Leader of Regulatory Affairs team; mentored/coached professionals.
• Experience coordinating product registration submissions and regulatory filings.
• Experience interacting with regulatory agencies to expedite approvals.

Responsibilities

• Supervises professionals in directing development of product registration submissions, progress reports, supplements, amendments or periodic experience reports.
• Interacts with regulatory agencies to expedite approval of pending registrations.
• Acts as regulatory liaison across the product lifecycle with marketing, research teams and agencies.
• Contributes to regulatory strategy, risk management and chemistry manufacturing control (CMC).
• Advises on manufacturing changes, line extensions, labeling and regulatory interpretations.
• Ensures timely approvals of new drugs, biologics or medical devices and continued approvals of marketed products.

Job description

## Manager Regulatory AffairsApply: India - Mumbai: Full time: Posted Today: 31162843## **JOB DESCRIPTION:**## **Main Purpose of the Role*** **Summarize the main purpose of the role**Leads/supervises a team of more than 2 professionals within the Regulatory Affairs Sub-Function. First level manager of a work team that may comprise professionals, technical and/or administrative staff. Typically without budget or hire/fire authority. Focuses on mentoring, coaching, and coordination.## **Main Responsibilities*** **List the main responsibilities this role regularly performs.**As the Team Leader (Professionals) of the Regulatory Affairs Sub-Function, supervises professionals in directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports.Interacts with regulatory agency to expedite approval of pending registration.Serves as regulatory liaison throughout product lifecycle.Participates in some of the following: product plan development and implementation, regulatory strategy, risk management, chemistry manufacturing control (CMC).Ensures timely approval of new drugs, biologics or medical devices and continued approval of marketed products.Serves as regulatory representative to marketing, research teams and regulatory agencies.Advises development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations.**The base pay for this position is**N/AIn specific locations, the pay range may vary from the range posted.## **JOB FAMILY:**Regulatory Operations## **DIVISION:**EPD Established Pharma## **LOCATION:**India > Mumbai : BKC Building## **ADDITIONAL LOCATIONS:**## **WORK SHIFT:**Standard## **TRAVEL:**Not specified## **MEDICAL SURVEILLANCE:**Not Applicable## **SIGNIFICANT WORK ACTIVITIES:**Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)