Manager Regulatory Affairs

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.
The base pay for this position is
N/A
In 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)