Manager Regulatory Affairs
Abbott · Mumbai Metropolitan Region
- Experience5–8 yrs
- SalaryNot disclosed
- Work modeonsite
- Posted29 Sept 2026
About Abbott
Abbott is hiring in Mumbai Metropolitan Region in healthcare. This role looks for around 5+ years of experience.
Skills
- Regulatory affairs
- Product registration
- Regulatory strategy
- Risk management
- Chemistry manufacturing control
- Regulatory compliance
- Drug development
- Biologics
- Medical devices
- Technical labeling
The role
A regulatory affairs manager at a healthcare products company develops product registration submissions, guides regulatory strategy, and coordinates approvals for drugs, biologics, and medical devices, applying risk management and chemistry manufacturing control expertise while advising development and marketing teams on regulations and labeling.
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.