Job Description Summary
Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this current and ambitious path, unique opportunities will present themselves, both professionally and personally. Join us, 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 & 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 unit customers.
Job Description
Your Key Responsibilities:
Your responsibilities include, but not limited to:
Manages medium to small level global regulatory submission projects.
Provide submission and contribute to the technical related regulatory strategy, intelligence and knowledge required to develop, register, and maintain global products.
Contribute to strategic and technical input /support to drive implementation of global systems, tools and processes to support global development projects and/or marketed products.
Frequent internal company and external contacts.
Represents organization on specific projects -Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors.
Reporting of technical complaints / adverse events /
📌 Specialist - RA (Mumbai)
🏢 Sandoz
📍 Mumbai