Sr. Executive- Regulatory Affairs

4 days ago

Navi Mumbai, Maharashtra, India Titan Laboratories Full time ₹ 15,00,000 - ₹ 25,00,000 per year

Role & responsibilities

Dossier Preparation and Submission:

  • Compile and review regulatory submissions in ACTD, CTD and formats.
  • Ensure all regulatory documents are accurate, complete, and compliant with regulatory requirements.
  • Review of Plant and R&D Data:
  • Review R&D data to confirm compliance with regulatory expectations and assist in developing effective submission strategies.
  • Regulatory Compliance and Updates:
  • Stay informed of changes in Asian or Regulated market regulations, ensuring timely implementation of updates to maintain compliance.
  • Provide regulatory insights to internal teams on best practices for data management and documentation.
  • Documentation and Record Keeping:
  • Maintain well-organized records of submissions, communications, and approvals.
  • Use regulatory software and systems for document tracking, version control, and report generation.

Markets - Regulated (EU/UK/Aus) or ROW (Asia & Africa)

Desirable Skills & Competencies:

  • Attention to Detail: Ability to review and analyze technical documentation with precision.
  • Collaboration: Effective communication skills for working with R&D, manufacturing, and quality assurance teams.
  • Problem Solving: Proactive in identifying compliance issues and developing solutions to address regulatory challenges.
  • Proficient in MS Office and regulatory documentation software.

Interested candidates can apply or mail your resume on or -contact Ext 725).

If you have good references you can share on above details.

Thanks & Regards,

Vaibhavi Behere

HR Department

Titan Laboratories Pvt Ltd

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