Regulatory Compliance Specialist

4 days ago

Hyderabad Secunderabad Telangana, India beBeeRegulatoryAffairs Full time ₹ 1,04,000 - ₹ 1,30,878
Job Summary

As a Regulatory Affairs Manager, you will play a key role in supporting the implementation of automation and digital tools to streamline regulatory CMC documentation and submission workflows.

Key Responsibilities:

  • Develop and implement standardized templates and structured data formats to ensure consistent and compliant submissions.
  • Contribute to projects focused on applying AI and structured content/data management (SCDM) for regulatory use cases.
  • Coordinate with cross-functional teams to ensure alignment on automation initiatives and data standards.
  • Monitor industry trends and guidance to maintain up-to-date knowledge of digital and regulatory innovations.
  • Support the design and deployment of automated solutions for data extraction, conversion, and integration with regulatory platforms.

Requirements:

  • Doctorate degree OR Master's degree with 3 years of directly related experience OR Bachelor's degree with 5 years of directly related experience.
  • Experience managing and leading a team in a regulatory or compliance environment.

Preferred Qualifications:

  • Degree in life sciences, digital or data science, biochemistry, or chemistry.
  • Experience leading global regulatory CMC submissions with knowledge of ICH guidance and global requirements.
  • Background or experience in digitalization, automation, and software development.
Why This Role Matters

This position is responsible for ensuring the smooth operation of our regulatory processes. The ideal candidate will have a strong understanding of regulatory requirements and be able to communicate effectively with cross-functional teams.

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