Teva Pharmaceuticals hiring Regulatory Affairs Associate II in Navi Mumbai. Explore detailed responsibilities, eligibility, skills, and complete application steps.
Teva Pharmaceuticals, one of the world’s leading manufacturers of generic medicines, has opened an excellent opportunity for the role of Regulatory Affairs Associate II at its Navi Mumbai location. Known for its global presence in over sixty countries and its contribution to essential medicines used worldwide, Teva offers a strong platform for regulatory professionals seeking career growth, global exposure, and hands-on experience in FDA-related submissions and post-approval change management. Teva Pharmaceuticals Hiring Regulatory Affairs Associate II
This long-format article provides an in-depth explanation of the role, including responsibilities, required qualifications, skills, and the complete application procedure. Whether you are an experienced regulatory professional or someone with a background in QA, analytical labs, or pharmaceutical production, this position could be a major stepping-stone in your professional journey. Teva Pharmaceuticals Hiring Regulatory Affairs Associate II
Key Highlights
| Particular | Details |
|---|---|
| Company Name | Teva Pharmaceuticals |
| Job Role | Regulatory Affairs Associate II |
| Job Location | Navi Mumbai, Maharashtra |
| Job ID | 64918 |
| Experience Required | Minimum 4+ years in pharmaceutical industry |
| Qualification Required | M.Pharm (RA/QA preferred) or equivalent pharma experience |
| Department | Regulatory Affairs |
| Application Mode | Online |
About Teva Pharmaceuticals
Teva Pharmaceuticals is a global pharmaceutical leader with a legacy of improving healthcare accessibility and affordability. The company produces high-quality generic medicines and innovative specialty products. Teva’s medicines are consumed by more than 200 million people every single day, demonstrating its global reach and trusted reputation. Teva Pharmaceuticals Hiring Regulatory Affairs Associate II
With a presence across nearly sixty countries, Teva brings together diverse professionals with expertise in science, regulatory affairs, quality assurance, research, and technology. The organization strongly promotes innovation, collaboration, and compliance with global regulatory standards. Employees get the opportunity to work on high-impact projects that directly contribute to improving patient outcomes worldwide.
Working at Teva means becoming part of a global mission dedicated to delivering safe, effective, and affordable healthcare solutions. Teva Pharmaceuticals Hiring Regulatory Affairs Associate II
Job Opportunity: Regulatory Affairs Associate II
The role of Regulatory Affairs Associate II is designed for experienced regulatory professionals who can independently handle regulatory submissions, annual reports, supplements, and post-approval documentation for the US FDA. This position requires moderate to minimal supervision and demands strong understanding of FDA regulations, ANDA submissions, change control evaluation, and compliance. Teva Pharmaceuticals Hiring Regulatory Affairs Associate II
The Associate II acts as a bridge between internal departments and regulatory teams, ensuring timely preparation, review, and submission of high-quality documents.
Comprehensive Roles and Responsibilities
Below is a detailed explanation of the responsibilities expected from the Regulatory Affairs Associate II: Teva Pharmaceuticals Hiring Regulatory Affairs Associate II
1. Prepare and Submit High-Quality FDA Regulatory Submissions
The primary responsibility includes preparing, reviewing, and submitting regulatory documents to the US FDA. These submissions must align with FDA guidance, company timelines, and standard regulatory practices.
2. Manage ANDA Annual Reports
The Associate II will maintain approved ANDA applications in full compliance with FDA regulations. This includes preparing annual reports, gathering supporting documentation, and publishing reports for management review.
3. Work on Supplements (Simple to Complex)
Under moderate direction, the Associate II will:
- Independently handle simple supplements
- Compile and publish supplement submissions
- Support management on more complex supplements to gain deeper experience in regulatory pathways
4. Evaluate Change Controls (Post-Approval Changes)
One of the most critical responsibilities involves assessing change controls intended for post-approval modifications. Duties include:
- Ensuring change control documentation is accurate
- Identifying missing information
- Consulting with the manager before advancing the CC
- Understanding regulatory impact through proper guidance review
5. Maintain Regulatory Databases and Trackers
Accurate and real-time database management is essential. The Associate II will:
- Maintain internal regulatory trackers
- Populate data consistently
- Ensure documentation is always audit-ready
6. Study and Stay Updated with FDA Guidelines
The candidate must regularly review FDA regulations, post-approval guidance documents, and newly issued regulatory updates to ensure accurate evaluation of change controls and submissions.
7. Support and Train Associate I Team Members
When required, the Associate II will also contribute to training junior regulatory professionals (Associate I) in:
- Internal processes
- Documentation standards
- Software systems
- Submission trackers
This helps improve team efficiency and strengthens the department’s overall compliance capability. Teva Pharmaceuticals Hiring Regulatory Affairs Associate II
8. Participate in Other Assigned Projects
As part of a global regulatory team, the associate may be assigned additional tasks depending on departmental needs, inclusing project support, quality audits, or data cleanup activities.
Required Qualifications and Experience
Educational Qualification
- M.Pharm (preferably in Regulatory Affairs or Quality Assurance)
- Candidates with strong pharmaceutical experience from laboratory, QA, analytical departments, or production may also be considered
Experience Requirements
- Minimum 4+ years of experience in the pharmaceutical industry
- Prior exposure to Regulatory Affairs, QA, analytical testing, or manufacturing documentation is beneficial
Technical Skills
- Proficiency in MS Word, Excel, and internet research
- Knowledge of ANDA submissions, supplements, and annual reports
- Understanding of FDA post-approval change guidelines
- Ability to handle regulatory documentation independently
Soft Skills
- Strong verbal and written communication
- Ability to work both independently and as part of a team
- Excellent organizational and time-management abilities
- Capability to manage multiple assignments and shifting priorities
- High level of attention to detail and accuracy
Why Choose a Career at Teva Pharmaceuticals?
Building a career at Teva offers regulatory professionals an opportunity to work with one of the most trusted pharmaceutical companies in the world. Benefits include:
- Exposure to global regulatory environments
- Chance to work on FDA-focused regulatory projects
- Opportunities for professional development and mentoring
- A diverse workplace with inclusive cultural values
- Advanced technology systems used for regulatory management
- Work with experienced teams that support learning and growth
Teva also ensures ethical work practices, adherence to compliance, and constant innovation to maintain global standards. Teva Pharmaceuticals Hiring Regulatory Affairs Associate II
Equal Employment Opportunity Commitment
Teva Pharmaceuticals strongly adheres to equal employment opportunity practices. The company ensures that hiring and employment decisions are made without discrimination based on age, religion, race, gender, disability, medical condition, sexual orientation, pregnancy, gender identity, national origin, or veteran status. Teva Pharmaceuticals Hiring Regulatory Affairs Associate II
Teva is committed to providing a respectful workplace. Candidates needing accommodations during the recruitment process can request assistance, and all information provided for this purpose remains confidential. Teva Pharmaceuticals Hiring Regulatory Affairs Associate II
How to Apply for Regulatory Affairs Associate II at Teva Pharmaceuticals
To apply for the Regulatory Affairs Associate II position, follow these steps: Teva Pharmaceuticals Hiring Regulatory Affairs Associate II
- Visit the official Teva Pharmaceuticals Careers website.
- In the job search bar, enter Job ID: 64918 or type Regulatory Affairs Associate II – Navi Mumbai.
- Open the job listing and review the complete details.
- Click on “Apply” or “Apply Now” to begin the application process.
- Register or log in using your email ID.
- Fill in the online application form with accurate details.
- Upload your updated resume and any supporting documentation.
- Review the form and submit your application.
Once submitted, Teva’s recruitment team will review your profile. If shortlisted, you will be contacted for the next steps, which may include interviews or assessments. Teva Pharmaceuticals Hiring Regulatory Affairs Associate II
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