Regulatory Affairs Publishing Specialist

1 week ago

Hyderabad Telangana Bangalore Karnataka, India beBeePublishing Full time ₹ 1,20,00,000 - ₹ 2,00,00,000
Regulatory Affairs Publishing Associate

This role is ideal for a highly skilled and experienced Regulatory Affairs professional who has expertise in regulatory publishing, document management, and stakeholder engagement. As a Regulatory Affairs Publishing Associate, you will play a key role in supporting global regulatory submission activities by managing electronic publishing, document-level, and submission-level tasks.

You will be responsible for compiling, formatting, and publishing regulatory submissions, including INDs, NDAs, BLAs, MAAs, ANDAs, CTAs, DMFs, 510k, PMAs, CE Marking documents, and other regional submissions. You will ensure adherence to eCTD NeeS and regional submission formats using tools such as Lorenz DocuBridge, Veeva Vault, and Extedo.

Additionally, you will conduct document-level and submission-level publishing with full version control, metadata tagging, hyperlinking, and bookmarking. You will perform detailed quality control checks and validation of regulatory submissions to meet global standards. You will also collaborate with cross-functional teams to define submission requirements, resolve issues, and align on publishing timelines.

The ideal candidate will have a graduate or postgraduate degree in Pharmacy, Life Sciences, or a related field, and 4-6 years of experience in Regulatory Publishing, document and submission level. You will have hands-on expertise in publishing tools like Lorenz DocuBridge, Veeva Vault, Extedo, and eCTD validation tools. You will also have a strong understanding of global submission standards, eCTD, NeeS, electronic gateways, ESG, IRIS, etc., and version control practices.

As a Regulatory Affairs Publishing Associate, you will work in a flexible work environment with hybrid remote options based on project client requirements. You may require occasional travel for stakeholder workshops or audits. If you are a motivated and detail-oriented individual with excellent communication and interpersonal skills, this role may be the perfect fit for you.



Key Responsibilities:
  • Regulatory Publishing: Compiling, formatting, and publishing regulatory submissions
  • Documentation Management: Managing electronic publishing, document-level, and submission-level tasks
  • Stakeholder Engagement: Collaborating with internal and external stakeholders to gather and finalize documents for submission
  • Business Analysis: Analyzing and defining regulatory business needs, identifying gaps, risks, and opportunities for submission process improvement

Required Qualifications:
  • Graduate or Postgraduate degree in Pharmacy, Life Sciences, or a related field
  • 4-6 years of experience in Regulatory Publishing, document and submission level
  • Hands-on expertise in publishing tools like Lorenz DocuBridge, Veeva Vault, Extedo, and eCTD validation tools
  • Strong understanding of global submission standards, eCTD, NeeS, electronic gateways, ESG, IRIS, etc., and version control practices

Benefits:
  • Opportunity to work in a flexible work environment with hybrid remote options
  • Potential for occasional travel for stakeholder workshops or audits
  • Competitive compensation and benefits package

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