Sr Specialist Regulatory Affairs : 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 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 > Recent 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) Experience Level Senior Level

📌 Senior Specialist - Regulatory Affairs (New Delhi)
🏢 Abbott India
📍 New Delhi