Teva Hiring Regulatory Affairs Associate II in Navi Mumbai Apply Now. for US FDA submissions role in global pharmaceutical regulatory careers India.
Teva Pharmaceuticals is inviting applications for the role of Regulatory Affairs Associate II at its Navi Mumbai location. This opportunity is ideal for experienced regulatory professionals with exposure to US FDA submissions and post-approval regulatory activities. The role focuses on handling regulatory documentation, annual reports, and supplements in compliance with FDA guidelines.
Candidates with experience in regulatory affairs, quality assurance, or pharmaceutical development will find this role valuable for advancing their careers in global regulatory operations. Teva Hiring Regulatory Affairs Associate II
Company Overview
Teva Pharmaceuticals is a globally established biopharmaceutical company known for its extensive generics portfolio and specialty medicines. Operating across multiple therapeutic areas and markets, Teva plays a key role in delivering affordable healthcare solutions worldwide. The company offers strong global exposure, collaborative work environments, and structured career progression in regulatory and pharmaceutical domains.
Teva Hiring Regulatory Affairs Associate II
Job Location & Employment Type
- Location: Navi Mumbai, Maharashtra (400706)
- Employment Type: Full-time
- Department: Regulatory Affairs
- Job ID: 64918
Role Overview
The Regulatory Affairs Associate II will support US regulatory operations, primarily focusing on post-approval submissions and lifecycle management activities. The selected candidate will prepare and review regulatory submissions, manage annual reports for ANDAs, and ensure compliance with FDA requirements.
This role requires the ability to work independently with minimal supervision while maintaining accuracy in regulatory documentation and database management. Teva Hiring Regulatory Affairs Associate II
Key Roles & Responsibilities
The selected professional will contribute to regulatory lifecycle management activities, including:
- Preparing and submitting regulatory documents in compliance with FDA requirements.
- Managing post-approval submissions such as annual reports and supplements.
- Maintaining approved applications in line with regulatory standards.
- Compiling and reviewing documentation for ANDA annual reports.
- Independently working on simple regulatory supplements.
- Supporting complex submission activities under managerial guidance.
- Evaluating change controls related to post-approval changes.
- Ensuring accuracy and completeness of regulatory documentation.
- Updating regulatory databases and trackers in real time.
- Reviewing regulatory guidance documents to enhance knowledge of FDA requirements.
- Supporting internal training of junior regulatory associates.
- Managing multiple regulatory priorities and deadlines.
- Handling additional regulatory projects as assigned.
Teva Hiring Regulatory Affairs Associate II
Eligibility Criteria
Educational Qualification
- M.Pharm in Regulatory Affairs or Quality Assurance (preferred)
- Equivalent pharmaceutical or life sciences qualifications may also be considered.
Experience
- Minimum 4+ years of experience in the pharmaceutical industry.
- Experience in regulatory affairs preferred.
- Backgrounds in QA, analytical development, production, or laboratory functions may also be considered.
Required Skills
Candidates should possess the following competencies:
- Knowledge of US FDA regulatory requirements.
- Experience in ANDA lifecycle management and submissions.
- Strong documentation and data accuracy skills.
- Familiarity with regulatory databases and trackers.
- Basic proficiency in MS Office tools (Word, Excel).
- Strong organizational and multitasking abilities.
- Ability to work both independently and in teams.
- Effective written and verbal communication skills.
- Detail-oriented approach with strong time management.
Salary & Benefits
Teva offers competitive compensation and employee-focused benefits, including: Teva Hiring Regulatory Affairs Associate II
- Salary as per industry standards
- Flexible work policies (role dependent)
- Paid leave and wellness programs
- Learning and development platforms
- Internal mobility and career growth opportunities
Employees also benefit from global learning initiatives and structured career development tools. Teva Hiring Regulatory Affairs Associate II
Selection Process
The recruitment process typically includes:
- Online application submission
- Initial screening and HR interaction
- Technical/regulatory interviews
- Final selection and offer
Shortlisted candidates will be contacted by Teva’s recruitment team.
How to Apply
Interested candidates should apply through the official Teva careers portal. Ensure your resume highlights US regulatory experience, ANDA exposure, and post-approval submission expertise. Teva Hiring Regulatory Affairs Associate II
Why Apply for This Pharma Job?
This opportunity offers strong exposure to global regulatory environments and US FDA lifecycle management. Key advantages include: Teva Hiring Regulatory Affairs Associate II
- Work with a globally recognized pharmaceutical company
- Exposure to US FDA regulatory submissions
- Hands-on experience with ANDA lifecycle management
- Career growth in international regulatory affairs
- Opportunity to mentor junior professionals
- Access to global regulatory learning platforms
Professionals targeting long-term careers in global regulatory affairs will benefit significantly from this role.
Important Disclaimer
IndiaPharmaJobs.in is an independent job information platform that shares pharmaceutical job updates for informational purposes only. We are not affiliated with Teva Pharmaceuticals or any employer. Candidates should verify all details and apply through official company channels. Teva Hiring Regulatory Affairs Associate II
Final Call-to-Action
If you have regulatory experience and want to work on US FDA submissions with a globally reputed pharmaceutical company, this Teva Regulatory Affairs Associate II role in Navi Mumbai is worth exploring. Apply now and advance your career in global regulatory affairs. Teva Hiring Regulatory Affairs Associate II
