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Manager Regulatory Affairs at Abbott — Mumbai

Experience3–4 yrs
SalaryNot disclosed
Work modeonsite
Posted29 Sept 2026

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About Abbott

Abbott is hiring in Mumbai in healthcare. This role looks for around 3+ years of experience.

Skills

Regulatory affairs
Product registration
Regulatory strategy
Chemistry manufacturing control
Risk management
Technical labeling
Product lifecycle management

The role

A regulatory affairs manager at a healthcare products company develops product registration submissions and regulatory strategy, guides drug, biologic, and medical device approvals, and advises on chemistry manufacturing control and technical labeling. The role also applies risk management and product lifecycle oversight.

Full job description

Main Purpose of the Role

Summarize the main purpose of the roleLeads/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.