Assistant Manager – Submission Publishing

Abbott Laboratories; Mumbai; On-site; INR 900,000 - 1,200,000; Full time

Job summary

Abbott Laboratories in Mumbai is seeking an experienced Regulatory Affairs professional who can work under limited supervision to apply subject matter knowledge in regulatory submissions and lifecycle management.

The role involves directing registration submissions, liaising with regulatory authorities, and contributing to regulatory strategy, risk management, and CMC activities across drugs, biologics, or medical devices as applicable.

Qualifications

• Minimum 1 year experience in regulatory affairs.
• Experience with regulatory submissions and monitoring across product lifecycle.

Responsibilities

• Direct development of product registration submissions and reports.
• Interact with regulatory agencies to expedite approvals.
• Serve as regulatory liaison across the product lifecycle.
• Contribute to regulatory strategy, risk management and CMC.
• Advise development and marketing teams on labeling and regulatory interpretations.

Skills

Regulatory affairs

Stakeholder management

Education

Associates Degree

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