Senior Documentation Specialist

3 days ago

India beBeeDocumentation Full time ₹ 15,00,000 - ₹ 25,00,000

As a seasoned professional, you will play a pivotal role in shaping the future of our company. You will be responsible for maintaining a controlled documentation system, ensuring record retention and information services are in accordance with regulatory requirements. Your expertise will ensure compliance to the requirements from regulatory agencies.

Maintain Documentation Change System

You will maintain the technical and non-technical documentation change system, assuring procedures are in place to classify and maintain records. Your attention to detail will ensure all documentation formatting standards, policies, and operating procedure requirements are met.

  • 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

Responsibilities include:

  1. New submissions in Most of World (MoW) regions and its planning as per targets
  2. Maintaining product history as per defined timelines and processes
  3. Authoring 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
  4. Organizing 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
  5. Managing administrative changes and super grouping variations submissions
  6. Preparing CMC responses to health authority questions during development, registration, and product lifecycle

Skills Desired:

  • Regulatory Compliance
  • Document Control
  • CMC Regulatory Strategies
  • Technical Writing
  • Project Management

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