Manager Regulatory Affairs | Abbott | Delhi

Job Description

Purpose:

• This role would be accountable for routine updates for Abbott applications submitted to the Centre, State and other relevant regulatory authorities for EPD India products.
• The responsibilities would be including but not be limited to submitting Abbott applications to Center/State/other regulatory bodies and following up with officials of these agencies for licenses, approval, and query letters.
• This role would be considered as a highly experienced and knowledgeable resource within the organization in directing the development of product registration submissions, progress reports, supplements, amendments, or periodic experience reports.
• Adapts precedent and may make significant departures from traditional approaches to developing solutions.
• Comprehensive knowledge in the area of Regulatory Affairs.

Job Description:

• Regulatory applications for follow-up of New Drugs, SND, FDC, Import & Registration, Biological, and Medical device applications filled at CDSCO.
• Samples submissions and follow-up with IPC Ghaziabad /Zonal office Ghaziabad CDSCO /Sadiq Nagar CDSCO/NIB, Noida/CDL, Kasauli for any assigned task.
• Prioritizing, planning, and monitoring allocated projects/applications against defined timelines.
• Online and offline submission & collection of all communications to CDSCO/IPC/Zonal office/Sadiq Nagar CDSCO/ NIB, Noida, etc.
• Responsible for document submission like dossier submission, PSUR, SAE, query reply, etc.
• Responsible for follow-up of Subject Expert Committee invitations and coordinating the CDSCO for proposal.
• Responsible for creating and updating the database for all submissions & approvals from CDSCO and other relevant govt bodies.
• Able to perform any task assigned for CDSCO/IPC/Zonal office/Sadiq Nagar CDSCO/ NIB, Noida, etc time to time by Senior management.
• Monitoring the notifications/notices/circulars/GSR/orders to create and update the database for further identifying the impact on business.
• Interacts with regulatory agencies to speed up approval of pending registration.
• Coordination with Internal Stakeholders for documentation required for Import license application and successful submission of Form 10.
• Ensures timely approval of new drugs, Subsequent New Drugs, biologics, or medical devices and continued approval of marketed products and well versed with CMC information-related queries raised by Regulatory Authority.
• Responsible for resolving issues of CDAC to avoid any technical glitches raised during the submission of applications in the Sugam system.
• Regularly gets updated and self-trained with the latest regulations on drugs in the country.

Experience Details:

Regulatory Affairs exp. Minimum 7-10 years in Pharmaceuticals, Biosimilars, vaccines, etc.

Minimum Education:

B.Pharm, M. Pharm, M.Sc.