Biologics Licensing Specialist

4 days ago

Kolkata, West Bengal, India beBeePublishing Full time ₹ 14,40,000 - ₹ 20,16,000
Job Description

We are seeking a highly skilled Regulatory Publishing Specialist to join our team in preparing and managing Biologics License Applications (BLA) in electronic Common Technical Document (eCTD) format using Veeva Vault.

The successful candidate will be responsible for compiling, formatting, and publishing regulatory documents to meet global health authority requirements. This includes evaluating compliance with regulatory guidelines and internal processes, as well as performing quality control on electronic submissions, including file structure and metadata.

Collaboration with cross-functional teams is essential to gather content and manage submissions. The ideal candidate must have strong organizational skills, attention to detail, and effective communication skills for collaboration with multiple stakeholders.

  • Key Responsibilities:
  • Prepare and manage BLA submissions in eCTD format using Veeva Vault.
  • Compile, format, and publish regulatory documents to meet global health authority requirements.
  • Evaluate compliance with regulatory guidelines and internal processes.
  • Perform quality control on electronic submissions.
Required Skills & Qualifications

The following skills and qualifications are essential for this role:

  • Expertise in Veeva Vault for BLA submissions.
  • Knowledge of global regulatory requirements.
  • Hands-on experience in preparing electronic sequences and publishing dossiers.
  • Detailed attention to detail with strong organizational skills.
  • Effective communication skills for collaboration with multiple stakeholders.
Benefits

This role offers a challenging and rewarding career opportunity in the Life Sciences industry. As a Regulatory Publishing Specialist, you will have the opportunity to work with a talented team of professionals and contribute to the success of our organization.

Others

Please note that prior experience in Life Sciences or Pharma regulatory publishing is essential for this role.

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