Regulatory Affairs Associate I

Roles & Responsibilities:
• Prepare ANDA Annual Reports, supplements, and amendments in compliance with US FDA guidelines
• Support change control evaluations and review documents such as batch manufacturing records, analytical methods, specifications, and validation reports
• Maintain regulatory databases, trackers, and submission logs accurately
• Assist senior regulatory staff in FDA filing determinations
• Ensure approved applications remain compliant with FDA regulations throughout the product lifecycle
• Participate in cross-functional regulatory and quality projects
• Support ANDA lifecycle management and global compliance activities

Qualification:
• M.Pharm (Master in Pharmacy) in Regulatory Affairs or Quality Assurance (preferred)

Experience:
• Minimum 2 years of experience in Regulatory Affairs, OR
• Experience in QC, Analytical, R&D, Manufacturing, or Pharmaceutical Production with regulatory exposure

Skills:
• Strong knowledge of FDA regulations and ANDA processes
• Experience with regulatory submissions and lifecycle management
• Proficiency in MS Word, Excel, and regulatory documentation tools
• High attention to detail and documentation accuracy
• Strong written and verbal communication skills
• Ability to manage multiple priorities and work in cross-functional teams

About the Organization:
Teva Pharmaceuticals is a global pharmaceutical leader in generic and specialty medicines, operating in numerous international markets. The company is known for its strong regulatory expertise, robust compliance systems, and commitment to delivering affordable, high-quality healthcare solutions worldwide.