Specialist Regulatory Affairs

Abbott; India; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Abbott is seeking an experienced Regulatory Affairs professional in India to support product registration submissions and lifecycle management. The role requires collaborating with regulatory authorities to expedite approvals and acting as a regulatory liaison across development, marketing, and research teams.

Responsibilities include contributing to regulatory strategy, risk management, and CMC discussions, while advising on manufacturing changes and labeling in line with regulatory

Qualifications

• Minimum 1 year of experience in Regulatory Affairs.
• Associates Degree is required.

Responsibilities

• Direct development of product registration submissions, progress reports, supplements, amendments, or periodic experience reports.
• Interact with regulatory agencies to expedite approval of pending registrations.
• Serve as regulatory liaison throughout the product lifecycle.
• Contribute to regulatory strategy, risk management, and CMC considerations.
• Advise development and/or marketing teams on manufacturing changes and labeling within regulatory frameworks.

Education

Associates Degree (± 13 years)

Job description

Job Description:

MAIN PURPOSE OF 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.

Education

• Associates Degree (± 13 years)

Experience/Background

• Minimum 1 year