Regeneron Hiring Regulatory Publishing Specialist

Regeneron Hiring Regulatory Publishing Specialist | Bengaluru, India

Regeneron, a leading biotechnology company, is looking for a Regulatory Publishing Specialist to join its Global Development team in Bengaluru, Karnataka. If you have expertise in regulatory publishing and submission processes, this is a great opportunity to work with an innovative organization committed to transforming healthcare.

About Regeneron

Regeneron is a pioneering biotechnology company dedicated to discovering, developing, and commercializing life-changing medicines for serious diseases. With cutting-edge scientific approaches, the company is redefining drug development, manufacturing, and commercialization on a global scale.

Job Role: Regulatory Publishing Specialist

Key Responsibilities

• Format and publish submission components per regional regulatory specifications (e.g., FDA, EMA, ICH, JP, etc.).
• Compile and validate electronic submissions using Lorenz Docubridge.
• Dispatch finalized submissions through regulatory authority portals and archive in Veeva Vault.
• Manage routine submissions and assist in creating submission structures.
• Provide mentorship on best practices for documentation and submission.
• Develop and maintain regulatory document processing and publishing standards.
• Identify regulatory system improvement opportunities and address technical issues.
• Collaborate with vendors for regulatory submission document tasks.
• Support regulatory inspections and audits as required.

Required Qualifications & Skills

• Education: Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, or a related field.
• Experience: Minimum 2 years of experience in Regulatory Operations.
• Strong knowledge of FDA, EMA, ICH, and other global regulatory guidelines.
• Proficiency in Microsoft Word, Adobe Acrobat, and electronic document management systems.
• Experience with document authoring templates, publishing tools, eCTD validation tools, XML.
• Familiarity with Veeva Vault & Lorenz Docubridge is preferred.

How to Apply?

Interested candidates can apply directly through Regeneron’s official website:
👉 Apply Now

Courses Relevant to Required Education

Candidates with the following educational backgrounds may be eligible:

• Life Sciences: Biotechnology, Microbiology, Biochemistry, Genetics, Molecular Biology
• Pharmacy: B Pharm, M.Pharm, Pharmaceutical Sciences
• Regulatory Affairs & Operations: Clinical Research, Regulatory Science, Drug Development, Biomedical Engineering

Job Summary Table