Regulatory Affairs Associate Job at Teva Pharmaceuticals
Teva Pharmaceuticals is hiring a Regulatory Affairs Associate I in Navi Mumbai, India. This full-time Regulatory Affairs Job role is ideal for M. Pharm professionals with experience in Regulatory Affairs, QA, QC, R&D, or pharmaceutical manufacturing who want to work on FDA submissions, ANDA annual reports, and regulatory compliance within a global generic pharma leader. Graduates seeking M Pharma jobs or Pharmacy jobs can apply now.
Job Details
- Job Title: Regulatory Affairs Associate I
- Job Location: Navi Mumbai, Maharashtra, India
About the Company
Teva Pharmaceuticals is one of the world’s leading manufacturers of generic medicines, operating across nearly 60 countries. Teva produces many medicines listed on the World Health Organization’s Essential Medicines List and helps over 200 million people worldwide access affordable healthcare every day. This Regulatory Affairs Job role plays a significant role in the company.
Educational Requirements
- M. Pharm degree (Regulatory Affairs / Quality Assurance preferred)
- Minimum 2 years of experience in Regulatory Affairs or pharmaceutical QA, QC, R&D, laboratory, or production functions
Key Responsibilities
- Prepare ANDA Annual Reports under direct supervision in compliance with FDA guidelines
- Assist in the preparation of supplements and amendments for FDA submissions as experience grows
- Review change control documentation, including batch records, methods, and specifications
- Support evaluation of regulatory filing determinations related to change controls
- Maintain approved applications in compliance with FDA regulations
- Accurately populate and maintain regulatory databases and trackers in real time
- Support regulatory documentation activities assigned by the manager
- Execute additional regulatory projects and duties as required
Skills Required
- Basic understanding of US FDA regulations and ANDA submissions
- Strong documentation and regulatory compliance skills
- Proficiency in Microsoft Word and Excel
- Good verbal and written communication skills
- Strong attention to detail and organizational abilities
- Ability to multitask and manage changing priorities
- Ability to work independently and collaboratively within teams
Why This Job Role?
This Regulatory Affairs Job role offers hands-on exposure to US FDA regulatory submissions within a global pharmaceutical organization. It is an excellent opportunity for early-career Regulatory Affairs professionals to strengthen their FDA compliance expertise, ANDA lifecycle knowledge, and global regulatory career growth at Teva Pharmaceuticals. Graduates seeking M Pharma jobs or Pharmacy jobs can apply now.
