Post Approval - Formulation Regulatory Specialist

Role - Post Approval - Formulation Regulatory Affairs - US/EU Level - Associate Manager/ Manager - Global Market (US,Canada,Europe) Required Education/Ex p: Experience Req.: 10 - 15 yrs. Qualification: - M. Pharma / M.Sc. Managing Product life cycle management for approved products in US, EU/Aus/Canada/ROW etc i.e. variation, Renewal and sunset exemption filings. Preparation and submission of PADERS, and Annual reports for US approved ANDAs Comprehensive and up-to-date knowledge on regulatory guidelines/requirements. Preparation and submission of PSURs for EU/UK approved MAAs Assessment of Change controls and provide regulatory assessments. Maintain of Post approval Regulatory Compliance Maintaining the necessary regulatory databases concurrently as on when regulatory updates are received. Supervise the team members on compilation of regulatory dossiers in accordance with US market requirements for post approval changes. Responsible for effective co-ordination with the cross functional teams at site and finalization of supplements to ensure effective data presentation and quality. Ensure timely submission of responses to the deficiencies received from the agency. Responsible to Identify, assess regulatory risks associated with assigned projects and timely communication of the issues, that impact to regulatory management & core team and drives resolution of issues. Responsible for the finalization of CTD sections of CMC post approval supplements. Required sk ills :- Hands on managing Post Approval activities. A stable candidate from Pharma company. Well versed with regulatory gui delines. Candidates with relevant exp., kindly share CVs to apply on :- rashmi.gupta@biocon.com Kindly mention below details while sharing CV :- Total Exp in Formulation Regulatory Affairs? Current CTC? Handling Post Approval Submission activities or not? Notice Period? Ready to work in Bangalore (onsite) ? (5 Days working) Show more Show less