Teva Pharmaceuticals is offering a career opportunity for the position of Regulatory Affairs Associate II in Navi Mumbai, Maharashtra. This role is suitable for experienced pharmaceutical professionals with knowledge of regulatory affairs, quality assurance, analytical operations, laboratory processes, or pharmaceutical production.
The selected candidate will support regulatory submissions to the US Food and Drug Administration (FDA), including Abbreviated New Drug Application (ANDA) annual reports, supplements, and post-approval regulatory activities. The role also involves reviewing change controls, maintaining regulatory databases, and ensuring that submissions meet applicable regulatory guidelines and company timelines.
Candidates with at least four years of pharmaceutical industry experience and strong attention to detail may find this opportunity relevant to their career goals.
Teva Recruitment 2026: Job Highlights
| Particulars | Details |
|---|---|
| Company | Teva Pharmaceuticals |
| Job Title | Regulatory Affairs Associate II |
| Department | Regulatory Affairs |
| Job Location | Navi Mumbai, Maharashtra |
| Experience Required | 4+ years |
| Preferred Qualification | M.Pharm in Regulatory Affairs or Quality Assurance |
| Other Relevant Experience | Regulatory, Analytical, QA, Laboratory or Production |
| Regulatory Authority | US FDA |
| Key Responsibilities | ANDA annual reports, supplements, change controls and regulatory submissions |
| Employment Type | Not specified in the supplied job description |
| Salary | Not disclosed |
| Application Mode | Online through the company’s careers portal |
About Teva Pharmaceuticals
Teva Pharmaceuticals is a global pharmaceutical company with a business spanning innovative medicines and generic pharmaceuticals. The company focuses on improving access to medicines and supporting patients’ healthcare needs worldwide.
Teva promotes collaboration, inclusion, professional development, and continuous learning. Employees may have opportunities to develop technical skills, work with global teams, and explore internal career opportunities.
Job Description: Regulatory Affairs Associate II
The Regulatory Affairs Associate II will prepare, review, compile, and support the submission of regulatory documents to the US FDA. The position requires the ability to manage assigned regulatory activities with moderate to minimal guidance while maintaining accuracy and meeting internal deadlines.
A major part of the role involves managing ANDA annual reports, supporting simple post-approval supplements, evaluating change controls, and ensuring that regulatory databases and trackers remain accurate and up to date.
The candidate will also collaborate with management and other team members to ensure that regulatory documentation is complete and compliant with applicable requirements.
Key Responsibilities
1. Regulatory Submissions and ANDA Annual Reports
- Maintain approved regulatory applications in accordance with FDA requirements.
- Manage assigned ANDA annual report activities.
- Proactively request the documentation required to prepare annual reports.
- Compile and publish regulatory documents for management review.
- Ensure that submissions are prepared accurately and within established timelines.
2. Post-Approval Supplements
- Independently handle assigned straightforward supplement activities under management’s direction.
- Compile and publish supplements for management review.
- Assist management with more complex supplements to gain further regulatory experience.
- Support the preparation of documentation related to post-approval changes.
3. Change Control Evaluation
- Review change controls intended for post-approval changes.
- Assess whether change-control documentation is complete and accurate.
- Refer change controls to the manager or designated reviewer before proceeding.
- Review relevant FDA post-approval guidance to understand regulatory requirements and assess proposed changes appropriately.
4. Regulatory Databases and Documentation
- Maintain regulatory databases, team trackers, and related records.
- Update information accurately and in real time, as directed by management.
- Support proper documentation management and internal regulatory processes.
- Help maintain reliable records for ongoing regulatory activities.
5. Team Support and Training
- Assist colleagues with regulatory processes and documentation when required.
- Provide training to Associate I team members on internal procedures, databases, and trackers when assigned.
- Work independently on routine tasks while collaborating with management and team members on more complex assignments.
6. Additional Responsibilities
- Undertake other projects and duties assigned by management.
- Maintain accuracy, organisation, and compliance across assigned activities.
- Manage changing priorities while meeting submission deadlines.
Eligibility Criteria
Educational Qualification
A Master of Pharmacy (M.Pharm) degree in Regulatory Affairs or Quality Assurance is listed as an advantage.
The job description does not state that this qualification is mandatory. Candidates should review the official vacancy page to confirm the complete educational requirements.
Work Experience
Applicants should have a minimum of four years or more of pharmaceutical industry experience.
Experience in the following areas is preferred:
- Regulatory Affairs
- Analytical operations
- Quality Assurance (QA)
- Laboratory operations
- Pharmaceutical production
Candidates with relevant pharmaceutical experience and an understanding of regulatory documentation may be well suited to the role.
Required Skills
Applicants should possess the following skills and capabilities:
- Basic computer proficiency, including Microsoft Word and Excel.
- Familiarity with internet-based research and documentation.
- Understanding of pharmaceutical regulatory requirements.
- Strong written and verbal communication skills.
- Ability to work independently and collaboratively.
- Good organisational skills and attention to detail.
- Ability to manage multiple tasks and changing priorities.
- Willingness to learn and interpret applicable FDA guidance.
- Accuracy in maintaining regulatory records and databases.
Knowledge of FDA Regulations and ANDA Submissions
This position focuses on US regulatory activities, making familiarity with FDA requirements particularly relevant.
An ANDA, or Abbreviated New Drug Application, is a regulatory application used for certain generic medicines in the United States. Annual reports and post-approval supplements support the maintenance of approved applications and the reporting or implementation of relevant changes.
The Associate II will contribute to these activities by compiling documentation, evaluating change controls, reviewing applicable guidance, and coordinating with management to ensure that regulatory work is completed appropriately.
Job Location
The position is based in Navi Mumbai, Maharashtra, India.
The supplied job description does not specify the exact office address, working hours, or remote-work arrangements. Candidates should check the official vacancy listing for further details.
Salary and Employee Benefits
The salary for the Regulatory Affairs Associate II position has not been disclosed in the supplied job description.
Teva India describes a range of employee benefits and development opportunities, including:
- Medical insurance.
- Outpatient department (OPD) coverage.
- Annual health checkups.
- Term life and accident insurance.
- Emotional wellbeing support through the Optum Employee Assistance Program.
- Meals at work and wellbeing initiatives.
- Volunteering and community programmes.
- Learning, continuing education, and mentorship opportunities.
- Opportunities to collaborate with global teams and explore internal career paths.
Eligibility for specific benefits may depend on the applicable employment terms and company policies.
How to Apply for Teva Recruitment 2026
Interested candidates can visit Teva’s official careers website and search for Regulatory Affairs Associate II – Navi Mumbai, India.
Application steps:
- Visit the official Teva careers website.
- Search for the job title “Regulatory Affairs Associate II”.
- Confirm that the vacancy location is Navi Mumbai, India.
- Review the complete job description and eligibility requirements.
- Submit your application through the official recruitment portal, following the instructions provided.
The link above leads to Teva’s careers website and is not a verified direct application link for this specific vacancy. Candidates should locate the matching position before applying.
Existing Teva employees should apply through the internal Twist career site, as instructed in the job description.
Frequently Asked Questions (FAQs)
1. What is the job title at Teva Pharmaceuticals?
The vacancy is for Regulatory Affairs Associate II.
2. Where is the Teva Regulatory Affairs job located?
The position is based in Navi Mumbai, Maharashtra, India.
3. How much experience is required?
The job description specifies a minimum of four years of pharmaceutical industry experience.
4. What qualification is preferred for this position?
An M.Pharm degree in Regulatory Affairs or Quality Assurance is listed as an advantage.
5. Which areas of experience are preferred?
Experience in Regulatory Affairs, Analytical operations, Quality Assurance, laboratory work, or pharmaceutical production is preferred.
6. What are the main responsibilities of the Associate II?
Responsibilities include preparing ANDA annual reports, supporting post-approval supplements, evaluating change controls, maintaining regulatory databases, and preparing documents for management review.
7. Does this role involve working with the US FDA?
Yes. The role involves preparing, reviewing, and supporting regulatory submissions to the US FDA in accordance with applicable guidelines.
8. What is the salary for this position?
The salary has not been disclosed in the supplied job description. Candidates can seek compensation details from the employer during recruitment.
9. What benefits does Teva India offer?
The company describes benefits including medical insurance, OPD coverage, annual health checkups, life and accident insurance, wellbeing support, learning programmes, and professional development opportunities.
10. How can candidates apply?
Candidates can visit the official Teva careers website and search for the Regulatory Affairs Associate II vacancy in Navi Mumbai.
11. Is the application deadline available?
The supplied job description does not mention an application deadline. Candidates should check the official vacancy page for current availability and closing dates.
Disclaimer
This article is based on the job description supplied for the Teva Pharmaceuticals Regulatory Affairs Associate II position. Salary, application deadline, employment type, and certain work arrangements were not specified in the provided information. Vacancy details and eligibility criteria may change, so candidates should verify the latest information through Teva’s official careers portal before applying.