Job Description

Summary 2023 will see Sandoz become a standalone organization! 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, its 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.

Novartis