Assistant Manager - Submission Publishing

JOB DESCRIPTION:

MAIN PURPOSE OF THE ROLE

Experienced professional individual contributor that works under limited supervision.

Applies subject matter knowledge in the area of Regulatory Affairs.

Requires capacity to apply skills/knowledge within the context of specific needs or requirements.

MAIN RESPONSIBILITIES

- As the Experienced professional in the Regulatory Affairs Sub-Function, possesses well developed skills 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 Equivalent

Associates Degree ( 13 years)

Experience/Background

Experience Experience Details

Minimum 1 year

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)