Regeneron, a global leader in biotechnology, is seeking a Regulatory Publishing Specialist to join its Global Development team in Bengaluru, Karnataka. This is an exciting opportunity for professionals with expertise in regulatory publishing and submission processes to contribute to the development of life-changing medicines. If you have a passion for regulatory operations and a desire to work with an innovative organization, this role is perfect for you.
About Regeneron
Regeneron is a pioneering biotechnology company dedicated to discovering, developing, and commercializing innovative medicines for serious diseases. With a focus on cutting-edge science, Regeneron is transforming the way drugs are developed, manufactured, and brought to market. The company’s commitment to improving healthcare globally makes it a preferred employer for professionals in the pharmaceutical and biotechnology sectors.
Job Role: Regulatory Publishing Specialist
As a Regulatory Publishing Specialist at Regeneron, you will play a critical role in ensuring compliance with global regulatory standards. Your work will directly impact the company’s ability to deliver life-saving treatments to patients worldwide.
Key Responsibilities
- Format and publish submission components in compliance with regional regulatory specifications (e.g., FDA, EMA, ICH, JP).
- Compile and validate electronic submissions using tools like Lorenz Docubridge.
- Dispatch finalized submissions through regulatory authority portals and archive them in Veeva Vault.
- Manage routine submissions and assist in creating submission structures.
- Mentor team members on best practices for documentation and submission.
- Develop and maintain standards for regulatory document processing and publishing.
- Identify opportunities for improving regulatory systems and address technical issues.
- Collaborate with vendors to ensure timely completion of regulatory submission 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 of 2 years 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, and XML.
- Familiarity with Veeva Vault and Lorenz Docubridge is preferred.
