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Teva Pharmaceuticals, a global leader in generic medicines and a proud producer of WHO Essential Medicines, is hiring a Regulatory Affairs Associate I at their Navi Mumbai location. This role offers a fantastic opportunity to advance your career in regulatory affairs while contributing to affordable, high-quality healthcare for millions worldwide.
If you have a background in regulatory affairs, quality assurance, or pharmaceutical operations, and are passionate about FDA compliance and regulatory submissions, this role is perfect for you.
Key Responsibilities
- Prepare annual reports and assist in FDA supplements under direct supervision.
- Review change control documents, including batch records, specifications, and methods, ensuring accuracy and compliance.
- Maintain regulatory submissions databases and trackers in real time.
- Familiarize yourself with FDA regulations and guidance to support filing determinations.
- Ensure approved applications are compliant with FDA regulations for assigned ANDA annual reports.
- Support other regulatory and team projects as assigned.
Qualifications
- Educational Qualification: M. Pharma in RA/QA discipline preferred.
- Experience: Minimum 2 years in Regulatory Affairs and/or analytical/QC, R&D/laboratory, or production roles in the pharmaceutical/biotech industry.
- Skills:
- Proficient in Word, Excel, and internet research.
- Strong verbal and written communication skills.
- Detail-oriented, organized, and capable of managing multiple priorities.
- Ability to work independently and collaboratively.
Benefits
- Opportunity to work with a global leader in pharmaceuticals.
- Hands-on experience with FDA regulatory submissions and annual reporting.
- Exposure to cross-functional teams and career development opportunities.
- Inclusive and diverse work culture supporting professional growth.