Shilpa Medicare Ltd Walk In Interview 2023/Shilpa Medicare Ltd Notification full details below. Interested and eligible candidates can attend Interview on scheduled time and venue.Shilpa Medicare Limited (SML) started its operations as API manufacturer way back in 1987 at Raichur, Karnataka- India. The commercial production in the SML was started in November 1989. Today Shilpa Medicare Limited is a global brand in manufacturing and supplying of affordable API and Formulation globally in different regulated markets.
Vacancy details:
- Post Name: Regulatory Affairs-RoW -Executive/Senior Executive/Asst Manager
- Qualification: Any Graduate
- Experienced:02 to 7 yrs
Job Description: Greeting from Shilpa Medicare Ltd !!!
Important Details :
- Location: Nacharam, Hyderabad
- Post of date:16/02/2023
- Selection Process: The selection will be on the basis of Interview.
- Mode of Interview: Face to face
- Interview Rounds of Interview: HR
Walk-in Interview Details
Date: 17th Feb, 2023
Time: 10.00 AM – 4.00 PM
Venue:Shilpa Medicare Ltd. Address: Plot no 79, Road No 15, Survey No 125 IDA Mallpur, Nacharam, Uppal, Mandal, Telangana 500076
Roles and Responsibilities
- Responsible for product registration at MENA (Saudi Arabia, UAE, Bahrain, Oman, Jordan, Egypt, Morocco. Israel etc) region.
- Preparation, compilation and review of dossiers for MENA region in eCTD/CTD/country specific format.
- Co-ordinating with cross functional departments like API, R&D, QC, QA, PDD, Micro for documents required for dossier compilation for initial submission, query responses or other submission like tender activities.
- Communicating with agents/partners for submission of Dossiers and further updates or requirements if any on product registration.
- Responding to queries with in the time lines received from client/agency.
- Preparation of check list as per country specific requirements in MENA region.
- Review of documents like specifications/ MFC/ BMR/ PV/ Stability/ PDR/ DMF/ CoAs/Artworks and other quality related documents for their suitability for registration in MENA region.
- Co-ordinating for CoPP, GMP, License and other required documents/certificates legalization activity required for dossier compilation and registration.
- Archiving/Maintenance of the dossiers, renewal files and variation approvals along with supporting documents in regulatory data base.
- Identifying gaps in approved dossier, compiled and submit the post approval changes (Minor variations) to agent/agency.
- Filing of variations if any and registration renewals.
- Compilation and circulation of product approval package up on receipt of product approval/Minor variation approvals to concern departments.
- Maintaining the product status (Registered and Under registration) in excel sheet.
