Specialist Regulatory Affairs

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

Job summary

Abbott is seeking an Experienced Regulatory Affairs professional to operate under limited supervision. You will apply in-depth regulatory knowledge across drug, biologic, or device submissions, progress reports, supplements, and amendments.

You will interact with regulatory agencies to expedite approvals and serve as a regulatory liaison throughout the product lifecycle, advising development and marketing teams on regulatory requirements and labeling.

Qualifications

• Minimum 1 year of regulatory affairs experience.

Responsibilities

• Direct development of product registration submissions and related reports.
• Interacts with regulatory agencies to expedite approvals.
• Serves as regulatory liaison across product lifecycle.
• Contributes to regulatory strategy, CMC, labeling, and risk management.
• Ensures timely approvals for drugs, biologics or medical devices.
• Advises development and marketing teams on regulatory changes.

Skills

Regulatory affairs

Education

Associates Degree

Job description

• 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 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