Walk-ins For Regulatory Affairs- ROW & US/EU - Formulations

Roles and Responsibilities

Should Have Formulation Experience.

• Having vacancies in RoW (ASIA , MENA, LATAM, AFRICA) Regions And US/EU Region

• Responsible for product registration RoW (ASIA , MENA, LATAM, AFRICA) Regions or EU 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 Benefits