Senior Regulatory Affairs Publishing Manager

1 day ago

Bengaluru, Karnataka, India beBeeRegulatory Full time ₹ 1,75,00,000 - ₹ 2,50,00,000
Regulatory Affairs Professional Job Description

Our team seeks a skilled Regulatory Affairs Associate Senior to lead the publishing and dispatch of regulatory submissions for Devices & Drugs Submissions. Key responsibilities include:

  • Managing and leading regulatory publishing operations globally.
  • Ensuring submissions meet eCTD requirements and other regional formats.
  • Collaborating with cross-functional teams, including Regulatory Affairs, CMC, Quality, and Clinical, to plan submission strategies and timelines.
  • Overseeing timely publishing and dispatch of regulatory submissions using various tools.
  • Performing quality control checks to ensure technical and formatting compliance.

The ideal candidate will possess expertise in health authority gateways for submission dispatch, such as ESG, MHRA portal, CESP, and EMA portal. Strong knowledge of global regulatory standards (eCTD, NeeS, paper) and regional authority expectations is also required.

Requirements
  • Bachelor's or master's degree in Life science, regulatory affairs, or related field with 8+ years' experience in regulatory operations and significant hands-on publishing experience.
  • Strong technical skills and proficiency with publishing tools, such as Veeva Vault RIM, ISI Toolbox, eCTDXpress, ISI Publisher, Adobe Acrobat, ISI Writer, Excel, Microsoft word, Databases.
  • Excellent attention to detail, organizational skills, and ability to manage multiple priorities under tight deadlines.
  • Demonstrated leadership, coaching, or mentoring skills.
  • Excellent communication and interpersonal skills.

This role requires strong analytical and problem-solving skills, with the ability to work effectively in a fast-paced environment. The successful candidate will be a strategic thinker with excellent project management skills and the ability to deliver results in a timely manner.

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