Regulatory Affairs Officer | Gufic Group | Navsari

Job Description

• Provide samples & documents for regulatory filing to the regulatory department at HO & regulatory department of outside parties.
• Coordination with QC/Production/QA/ F & D for documents related to the dossier.
• Coordination with QC/ Production /QA/ F & D for samples & working standards for providing HO & regulatory department of outside parties.
• Review the documents received from QC/PRODUCTION/QA/ F & D before providing them to the regulatory department at HO & other parties.
• Coordination with HOD for replying to the queries received from parties and MOH.
• Preparation of therapeutic category master and formula master & product master of third party & own products of All Units (Injectables/ Ayurvedic/ Allopathic ointment) & other Unit.
• Collection of data from QA, QC, BSR, Production & HO for formula master & product master creation of third party & own products of Units.
• Coordination with all Unit stores & HO for material codes required for creating BOM.

Desired Candidate Profile

• Good In Communication
• Documents handling.
• Accurate Filing

Qualification: B.Pharma, M.PHarma