Tirupati Medicare Ltd is looking for Regulatory Affairs Executive for Domestic Market |walk-in interview on 5th Nov 23 (Sunday)
Tirupati Group is looking for Regulatory Affairs Executive for Domestic Market.
Interested candidates can apply on Naukri at given link or can attend the walk-in interview on 5th Nov 23 (Sunday).
Regulatory Affairs Executive
Experience: 3 – 7Years
Role & responsibilities:
Licensing and communication regarding the Pharma.
Preparation of Product preparation, Form-29, FSC, CT-10, MMC, CT-21, CoPP etc for pharma products.
Liasoning with the Government offices.
Review of application for product permissions and other FDA approval with DCGI/ State FDA.
Dealing with the queries related to the Pharma from various regulatory authorities as well as with MoH of various countries.
Review and Preparation for Dossier for Export and Domestic (Pharma).
Implementation of the Bar code on the export products.
Checking of Artworks of Domestic and Export products.
Day to day communication with the companies for their queries related to the various regulatory guidelines and product compliance as per the regulation.
Review of updates on DCGI and submission of suggestion to the regulators for change
Co-ordination of all the activities in the company and their compliance as per the current regulatory guidelines.
Handling of FDA/market complaints
Co-ordination and visit to regulatory Authorities CDSCO for various product/facility approval.
Review of agreements/NDA
Implementation of various provisions of NPPA.
Providing DPCO status and maintaining record of the same.
Preparation of response of ADR/ICSR under Pharmacovigilance guidelines by PvPI
Preparation of PSUR under Pharmacovigilance guideline by PvPI
Follow up with customer for ADR reporting
Day to day assigned work from HOD/ other organization.
Perks and benefits
Best in Industry.
Time and venue:
05th Nov, 9.30 AM – 5.30 PM
Tirupati Medicare Ltd., Nahan Road, Paonta Sahib, Himachal Pradesh – 173025
Contact – Monika Taluja
Tirupati is one of the largest and fastest growing company with pioneers in providing end-to-end solutions from research to product launch, with multiple state-of-the-art manufacturing facilities based at Paonta Sahib, a serene town on the foothills of Himachal Pradesh, India. We are the preferred choice of strategic partners in the Healthcare and Food Industry.
