MAIN PURPOSE OF ROLE

- Experienced qualified 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

📌 Specialist Regulatory Affairs (India)
🏢 Abbott Laboratories
📍 India