Regulatory Affairs Manager

Company Description

Founded in the commercial operations year of 2015-16, NextGen Pharma, a majority-owned subsidiary of Ormendes SA, Switzerland, has emerged as a leading provider of specialized botanical and nutraceutical solutions. With a focus on proprietary Targeted Bacterio-Therapy (TBT), our offerings cater to diverse therapeutic segments ranging from Gastrointestinal to Neurology

Role Description

This is a full-time on-site role for a Regulatory Affairs Manager located in New Delhi. The Regulatory Affairs Manager will be responsible for ensuring compliance with regulatory requirements, preparing and submitting regulatory documentation, and managing quality systems. Additional tasks will include coordinating with internal teams to align business strategies with regulatory requirements, and staying updated with new regulations and guidelines.

Qualifications

• Skills in Regulatory Compliance, Regulatory Requirements, and Regulatory Affairs
• Experience with Regulatory Submissions
• Proficiency in managing Quality Systems
• Strong organizational and time-management skills
• Excellent written and verbal communication skills
• Ability to work independently and meet deadlines
• Experience in the healthcare or pharmaceutical industry is a plus
• Bachelor's degree in a relevant field such as Regulatory Affairs, Life Sciences, or Pharmacy