Regulatory Affairs Specialist-II
Medtronic
Full time- 5+ years
- Not Disclosed
- Gurgaon, India
- Post Date: Apr 23, 2024
- End Date: Jun 23, 2024
- 5+ years
- Not Disclosed
- Gurgaon, India
- Post Date:Apr 23, 2024
- End Date: Jun 23, 2024
Skills:
- pharma
- pharmacovigilance
- Regulatory Affairs
Job Description:
Responsibilities
- Manage, plan and execute the preparation, review and submission of dossiers for product registrations, import licenses and other approvals from regulatory agencies (registrations and renewals) thereby supporting the business units and supply chain management in compliance with regulatory requirements in India.
- Coordination with global regulatory teams, local BU & other functions, for regulatory strategies and all documentation support required for regulatory submissions in India.
- Submit and track registration/re-registration applications with the authorities.
- Liaise with product divisions and obtain relevant details for filing changes to the approved products/licenses.
- Assess the Change controls from the product divisions through post approval change management and continuously ensure regulatory compliance (reporting of adverse events/field actions, etc.).
- Understanding & interpretation of law & the local regulatory requirement and implementing same in submission with compliance.
- Close monitoring of any changes in local & global regulations and communicating same within the department and respecting & following all SOP / system implemented within the department and organization.
- Ensure business continuity through regulatory filings, obtaining regulatory approvals and continuously ensuring regulatory compliance. Also ensure continuous implementation of the Quality Management System in India.
- Supporting the Marketing Teams on Tender related issues
- Development, implementation and maintenance of regulatory systems pertaining to regulatory document management (SOP's, archival, trackers and systems) within the department and organization.
- Interface and coordinate with regulatory agencies/competent authorities (CDSCO, CDDA, DGDA, State FDA, DoT, AERB, etc.) with respect to submissions, obtaining registrations/licenses, amendments, regulatory compliance, packaging, quality control testing or release, etc.
- Work with clinical team on submission and approval of clinical trials applications (clinical trial approvals, import licenses/test licenses for clinical trial, amendments, etc.) from various regulatory agencies in the India.
Qualification & Experience
- B Pharm / M Pharm / Bachelor or Master Degree in Bio-Medical Engineering / Science discipline with training in Regulatory Affairs
- Must have at least 5-7 years’ experience in the pharma/medical device/life science industry with at least 2-3 years' medical device experience in regulatory affairs
- Conversant with various regulatory requirements for India with respect to medical device registration, import, clinical trials, etc.
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Salary
Not Disclosed
-
Role
Specialist
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Area of Practice
- Regulatory Affairs
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Experience
5+ years
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