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Senior Regulatory Operations Associate

Senior Regulatory Operations Associate manages regulatory documents and submissions.
Precision for Medicine
On-Site
India
Undisclosed salary
Job Description
The Senior Regulatory Operations Associate role at Precision Medicine Group involves providing essential administrative and operational support to the Regulatory Affairs department. This role is pivotal in ensuring accurate, compliant, and timely submission of regulatory documents to bodies like the FDA and EMA. The Senior Regulatory Administrator supports the department by managing the organization of regulatory documents for submissions, ensuring compliance with relevant guidelines and regulations.

Role involves:
  • Uploading, organizing, and maintaining regulatory documents within submission portals.
  • Coordinating the redaction of confidential information in regulatory documents.
  • Preparing, formatting, and completeness checking documents for regulatory submissions.
  • Supporting the creation of regulatory submission packages.
  • Providing publishing and technical support for submission documents.
  • Assisting in auditing and reviewing regulatory submissions.
  • Maintaining tracking logs for submission timelines and document status.
  • Assisting with internal audits and inspections.
  • Mentoring and supervising junior Regulatory Administrators.
  • Resolving complex issues related to submission document upload and system functionality.
  • Contributing to process improvement and collaborating with cross-functional teams.
Requirements:
  • Bachelor’s degree or equivalent experience.
  • Computer literacy (MS Office/ Office 365).
  • Fluency in English, both written and verbal.
  • 3 years of experience in document management.
  • Previous experience in clinical research, regulatory affairs, or a related field is preferred.
  • Advanced knowledge of CTIS system and experience submitting clinical trial applications under the CTR is preferred.
  • Previous knowledge compiling and publishing, including eCTD is preferred.
  • Understanding of global regulatory requirements and guidelines is preferred.
  • Experience with document management systems and electronic submission formats is preferred.
Role offers:
  • Opportunity to work in regulatory operations.
  • Chance to mentor and supervise junior administrators.
  • Involvement in process improvement initiatives.
  • Collaboration with cross-functional teams.
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Precision for Medicine

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