Assistant Manager – Submission Publishing

Abbott; Mumbai; On-site; INR 600,000 - 900,000; Full time

Job summary

Abbott in Mumbai, India, seeks an experienced Regulatory Affairs professional to act under limited supervision, applying subject matter knowledge to regulatory submissions and lifecycle management. The role involves directing registration submissions, coordinating with regulatory authorities, and advising marketing teams on regulatory impacts.

The ideal candidate has at least 1 year of experience, an Associates Degree, and the ability to work cross-functionally to ensure timely approvals of

Qualifications

• Experience in directing development of product registration submissions and reports.
• Ability to interact with regulatory agencies to expedite approvals.
• Regulatory liaison throughout product lifecycle.

Responsibilities

• Direct development of product registration submissions, progress reports, supplements, or amendments.
• Interact with regulatory agencies to expedite approval of registrations.
• Serve as regulatory liaison across the product lifecycle.
• Support regulatory strategy, risk management, and CMC considerations.
• Ensure timely approvals for drugs, biologics, or devices and continued approvals.

Skills

Regulatory Affairs

Education

Associates Degree

Job description

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

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)