Regeneron is a leading biotechnology company dedicated to bringing groundbreaking medicines to patients with serious diseases. With a strong commitment to innovation, Regeneron pioneers new approaches in science, manufacturing, and commercialization. The company fosters an inclusive and diverse work environment, offering employees opportunities for growth, competitive benefits, and a dynamic workplace culture.
Job Title: Regulatory Publishing Specialist
Location: Bengaluru, Karnataka, India
Job ID: R38896
Department: Global Development
Job Description
Regeneron is seeking a Regulatory Publishing Specialist to join its dynamic team in Bengaluru. The ideal candidate will have expertise in formatting and publishing electronic regulatory documents, ensuring compliance with global regulatory standards (FDA, EMA, ICH, etc.).
Key Responsibilities:
- Format and publish electronic regulatory submissions (INDs, CTAs, BLAs, MAAs, JNDAs) in compliance with agency guidelines.
- Compile and validate submissions using Lorenz Docubridge and dispatch via regulatory portals.
- Archive submissions in Veeva Vault and manage regulatory documentation.
- Ensure adherence to regulatory submission standards and procedures.
- Assist in regulatory inspections and collaborate with vendors.
- Support system enhancements and troubleshoot technical issues.
Qualifications & Skills:
- Bachelor’s degree with 2+ years of regulatory publishing experience.
- Strong knowledge of FDA, EMA, ICH regulations.
- Proficiency in Microsoft Word, Adobe Acrobat, Veeva Vault, Lorenz Docubridge.
- Experience with eCTD validation, XML, and electronic document management systems (EDMS).
- Excellent attention to detail and problem-solving skills.
Why Join Regeneron?
- Innovative Work Environment: Contribute to life-changing medicines.
- Career Growth: Opportunities for professional development.
- Competitive Benefits: Health & wellness programs, bonuses, paid time off.
- Diverse & Inclusive Culture: Equal opportunity employer.
