CMC Manager

     

JOB DESCRIPTION:

MAIN PURPOSE OF 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

• 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.

QUALIFICATIONS

Education

Education Level

Major/Field of Study

Or

Education Level

Associates Degree (± 13 years)

 

☐

Experience/Background

Experience

Experience Details

Minimum 4 years

     

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:

Not Applicable