Publishing Specialist – Regulatory Affairs at Biocon Biologics

Biocon Biologics, a leading name in global biopharmaceutical innovation, is seeking a Publishing Specialist to join its Regulatory Affairs team in Bengaluru, Karnataka. This is an exciting opportunity for professionals skilled in eCTD publishing, regulatory submissions, and dossier management to advance their career with one of India’s most respected biotech companies.

If you’re passionate about regulatory compliance, documentation quality, and global health standards, this role offers the perfect platform to grow.

Key Responsibilities

• Prepare and submit high-quality electronic submissions (eCTD, NeeS) to global health authorities.
• Ensure all dossiers comply with ICH, EMA, and FDA regulatory guidelines.
• Use publishing tools such as Lorenz Docubridge, ISI Toolbox, eCTD Validator, Adobe Acrobat, MS Excel, and SharePoint.
• Perform document-level publishing, hyperlinking, bookmarking, validation, and quality control (QC) checks.
• Manage lifecycle submissions (variations, renewals, and amendments).
• Collaborate closely with Regulatory Affairs, CMC, and Clinical teams to maintain submission accuracy and consistency.
• Stay updated with evolving global regulatory publishing standards.

Qualifications and Skills

• Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Biotechnology, or a related field.
• 1–4 years of experience in regulatory publishing or submission management.
• Solid understanding of eCTD, NeeS, and ICH M4 guidelines.
• Hands-on experience with regulatory publishing tools (Lorenz Docubridge preferred).
• Attention to detail, time management, and ability to handle multiple global submissions.

Why Join Biocon Biologics?

• Work with a global leader in biopharmaceutical innovation and healthcare solutions.
• Collaborate on international regulatory submissions across developed and emerging markets.
• Access to continuous training and development programs.
• Competitive salary package (₹6–10 LPA) based on experience and expertise.
• Be part of a mission-driven organization improving patient access to affordable biologics.

Application Process

Application Link