Roles & Responsibilities
• Prepare ANDA Annual Reports, supplements and amendments in compliance with US FDA guidelines.
• Support change control evaluations and review supporting documents including batch manufacturing records, analytical methods, specifications and validation documents.
• Maintain regulatory databases, trackers and submission logs in real time.
• Assist senior regulatory staff in FDA filing determinations and submission strategies.
• Ensure approved applications remain compliant with FDA regulations throughout the product lifecycle.
• Participate in cross-functional regulatory and quality projects as assigned.
Qualification
• M.Pharm 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.
• Hands-on experience with regulatory documentation and submissions.
• Proficiency in MS Word, Excel and regulatory documentation tools.
• Strong written and verbal communication skills.
• High attention to detail with ability to manage multiple priorities.
• Ability to work independently and collaborate with cross-functional teams.
About the Company
Teva Pharmaceuticals is a global leader in generic and specialty medicines, committed to improving patient health by delivering high-quality, affordable healthcare solutions, with a strong global presence and robust regulatory and compliance systems supporting markets worldwide.
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