JOB DESCRIPTION:

MAIN PURPOSE OF ROLE
Summarize the main purpose of the role.
Specialist professional individual contributor with comprehensive knowledge in the area of Regulatory Affairs.
Ability to execute highly complex or specialized projects.
Adapts precedent and may make significant departures from traditional approaches to develop solutions.

MAIN RESPONSIBILITIES
•   As the Specialist in the Regulatory Affairs Sub-Function, considered as highly experienced and knowledgeable resource within the organization 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 7 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:

CRLB Core Lab

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)

Manager - Regulatory Affairs - CRLB - Mumbai

Abbott