Specialist Regulatory Affairs

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

Job summary

Abbott in New Delhi, India seeks an Experienced professional in Regulatory Affairs to work under limited supervision and apply subject matter knowledge to regulatory submissions and ongoing lifecycle support.

The role involves directing product registration submissions, liaising with regulatory agencies, and advising cross-functional teams on regulations and labeling. 1 year minimum experience preferred, with focus on regulatory strategies and CMC considerations.

Qualifications

• Associates Degree required.
• Minimum 1 year experience in regulatory roles.
• Experience with product registration submissions and regulatory submissions.

Responsibilities

• Directs development of product registration submissions, progress reports, supplements, amendments, or periodic experience reports.
• Interacts with regulatory agencies to expedite approvals.
• Serves as regulatory liaison throughout product lifecycle.
• Advises development and/or marketing teams on regulations, labeling and CMC requirements.

Skills

Regulatory affairs

Regulatory liaison

Product registration

Regulatory strategy

CMC (Chemistry Manufacturing Control)

Education

Associate degree

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.

QUALIFICATIONS

Education

Associates Degree (± 13 years)

Experience/Background

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: MD Medical Devices

LOCATION: India > New Delhi : New Friends Colony

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)