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
Date and Time:
12th September – 14th September , 2.00 PM – 5.00 PM
Shilpa Medicare ltd, Hyderabad Plot No 79, Survey No 125, IDA Mallapur, Uppal Mandal , Kaptra Municipality, Hyderabad, Hyderabad, Telangana, India
Contact – Karthik Kumar G
Job description
Roles and Responsibilities
Should Have Formulation Experience.
- Having vacancies in EU and RoW Region
- Responsible for product registration EU or RoW region
- Preparation, compilation and review of dossiers for 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 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.
Desired Candidate Profile
Should Have Regulatory Affairs Relevant Experience
Perks and BenefitsRole:
Legal & Regulatory – OtherIndustry Type:
Pharmaceutical & Life SciencesDepartment:
Legal & RegulatoryEmployment Type:
Full Time, PermanentRole Category:
Legal & Regulatory – Other
Education:
Any Graduate
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