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Regulatory Affairs Associate Senior 5-7Yrs

Regulatory Affairs Associate Senior 5-7Yrs

ConfidentialBengaluru / Bangalore, India
8 days ago
Job description

Job Description

Description :

Responsible for publishing, reviewing, archiving, and dispatching eCTD, NeeS or paper regulatory submissions for Devices & Drugs Submissions.

  • . Manage and lead regulatory publishing operations for global submissions.
  • . Ensure submissions meet the global eCTD requirements and other regional formats (NeeS, paper).
  • . Coordinate with a cross functional team including Regulatory Affairs, CMC, Quality and Clinical team to plan submission strategy and timelines.
  • . Oversee and ensure timely publishing and dispatch of regulatory submissions using various publishing tools (e.g. Veeva Vault RIM, eCTDXpress, Extedo, Lorenz).
  • . Perform quality control checks of published submissions to ensure technical and formatting compliance.
  • . Should have expertise in health authority gateways for submission dispatch i.e. ESG, MHRA portal, CESP, EMA portal.
  • . Implement and maintain publishing SOPs, work instructions, and quality standards.
  • . Develop training programs and mentor junior team members.

Qualifications :

  • . Bachelor's or master's degree in Life science, regulatory affairs or related field with 8 or more years' experience in regulatory operations with significant hands-on publishing experience.
  • . Strong knowledge of global regulatory standards (eCTD, NeeS, paper) and regional authority expectations (FDA, EU, Health Canada etc.)
  • . Strong technical skills and proficiency with publishing tools (Veeva Vault RIM, ISI Toolbox, eCTDXpress, ISI Publisher, Adobe Acrobat, ISI Writer, Excel, Microsoft word, Databases).
  • . Strong attention to detail, organizational skills and the ability to manage multiple priorities under tight deadlines.
  • . Candidate must be able to work in a team-oriented, fast-paced environment.
  • . Demonstrated leadership, coaching or mentoring skills.
  • . Excellent communication and interpersonal skills.

    • Skills Required

    isi toolbox , Databases, Microsoft Word, Excel, Adobe Acrobat

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