Senior Regulatory Writer

3 days ago

Mumbai, Maharashtra, India beBeeRegulatory Full time ₹ 9,00,000 - ₹ 12,10,000

We are seeking a seasoned regulatory writer to join our team.

About the Role:
  • This is an exciting opportunity for a highly skilled regulatory writer to develop and manage high-quality clinical and safety documentation for submission to regulatory authorities in support of marketing applications.
  • The successful candidate will provide authoritative guidance on documentation-related matters to other stakeholders within the organization.
  • They will also be responsible for coaching, mentoring, and training less experienced writers to ensure consistency and quality across all documentation.
Main Responsibilities:
  • Develop, review, and manage high-quality clinical and safety documents, including complex Clinical Study Reports, Risk Management Plans, CTD submission documents, clinical overviews, summaries of clinical efficacy and safety, and summaries of clinical pharmacology and biopharmaceutics.
  • Lead a writing team for complex submissions, contributing to key messaging and pooling strategy, providing expert content guidance for clinical portions of the CTD, and ensuring compliance with internal company standards and external regulatory guidelines.
  • Input into planning of data analyses and presentation, statistical analysis plan review, and meetings used in CSRs, submission documents, and answers to questions.
  • Ensure compliance with internal company standards and external regulatory guidelines as a documentation expert in GCTs and CSTs.
  • Provide strategic expertise for clinical portions of the CTD.
  • Report technical complaints, adverse events, special case scenarios related to products within 24 hours of receipt.
Key Performance Indicators:
  • Deliver high-quality clinical and safety documents on time and in compliance with internal and external standards.
  • Achieve customer, partner, project feedback, and satisfaction.
  • Adhere to policy and guidelines.

Contact Us:

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