Manager / Assistant Manager - Regulatory Affairs

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

Licenses and Certifications:

Language Proficiency
Language Proficiency

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)