Job Description

Summary Why Sandoz?
Almost 500 million patients were touched by Sandoz generic and biosimilar medicines in 2022 and while we\xe2\x80\x99re proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world.
We are at a pivotal moment in our history giving us the freedom to invest in our future, so we can continue to help millions of people access affordable high-quality medicines. Together we will shape the future of Sandoz, building an organization from the ground up and in return, experience an aspiration environment with impact, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged!The future is ours to shape!Ensures a controlled documentation system, record retention, and information services including electronic records retention processes in accordance with regulatory requirements. Ensures compliance to the requirements from regulatory agencies. Maintains the technical and non-technical documentation change system. Assures procedures are in place to classify and maintain records. Interprets and enforces all documentation formatting, standards, policies, and operating procedure requirements. May identify submission components, communicate documentation standards and coordinate assembly of regulatory dossiers. May analyze and evaluate data, extract pertinent information, prepare information abstracts and executive summaries of material searched. May maintain extensive knowledge of product information and continuous contacts with local, regional, and divisional customers.Major accountabilities:

• 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.

Novartis