Life cycle management of Marketing Authorizations (MAs). Core experience in new submissions and life cycle management in major markets EU/US/CAN/JP/AUS/BR/CN will be an added advantage. New submissions in Most of World (MoW) regions and its planning as per targets
Responsible for MA transfers and maintaining product history as per defined timelines and processes. Author high-quality CMC documentation (dossiers) for health authority submission, with support and guidance, applying agreed CMC regulatory strategies, assuring technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements throughout project lifecycle.
Organize high-quality CMC documentation (dossiers) for health authority submission, from license partners, applying agreed CMC regulatory strategies, assuring technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements throughout project lifecycle. Experience of handling work-sharing and super grouping variations strategy.
Prepare CMC responses to health authority questions during development, registration and product lifecycle. Regulatory evaluation of change controls and various other quality events (e.g. Deviations, OOS/OOT/OOE etc) for possible regulatory impact. Experience on managing administrative changes will be an added advantage.
Identify the required documentation for regulatory submissions and negotiate the delivery of approved technical source documents in accordance with project timelines. Experience of managing QP declarations, GMP certificates, CEPs, import permissions, COPP, legalizations, Apostille, translations, sample management as per global regulatory requirement
Identify content, quality and/or timeliness issues with source documents, or any other potential authoring issues that may impact submission quality or timelines, as early as possible. Keep knowledge upto date with regard to regulatory guidelines and requirements in all regions as well as for new technical trends.
Actively participate as a member of the global Reg CMC team by contributing to the regulatory strategy, identifying the critical issues and lessons learned. Establish and maintain sound working relationships with partners, stakeholders and customers.
Assume activities in support of the global databases and quality systems. Interactions with Health Authorities as and when required as per business requirements. Participation in special initiatives / projects of regulatory and manufacturing sites (as assigned by management) Training and mentoring Junior associate. Reviewing of the regulatory applications and variation packages prepared by associates. Regulatory project management.
