Job Description

Summary Sandoz as a global market leader in Generics and Biosimilar medicine, Sandoz is stepping forward from a position of strength! Those joining Sandoz in the coming months will help shape the future of the company, it\xe2\x80\x99s growth, innovation, culture and how Sandoz impacts the lives of millions. These will be careers with genuine impact! This is one such role!Are you ready to make a difference?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 & 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 work-sharing and super grouping variations submissions. 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 up to 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 RegCMC team by contributing to the regulatory strategy, identifying the critical issues and lessons learned.

Why Sandoz?Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more!With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.Our momentum and entrepreneurial spirit is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged!The future is ours to shapeSkills Desired Data Analysis, Document Management, Operational Excellence

Novartis