Teva Pharmaceuticals is hiring for the position of Regulatory Affairs Associate II in Navi Mumbai, India. The role focuses on preparing, reviewing, and submitting regulatory documents to the US Food and Drug Administration (FDA), maintaining approved applications, managing annual reports and supplements, and evaluating post-approval change controls.
Candidates with pharmaceutical industry experience in regulatory affairs, quality assurance, analytical functions, laboratory operations, or production can explore this opportunity.
Job Details
| Particulars | Details |
|---|---|
| Company | Teva Pharmaceuticals |
| Job Title | Regulatory Affairs Associate II |
| Job Location | Navi Mumbai, India |
| Experience | Minimum 4+ years |
| Qualification | M.Pharm in Regulatory Affairs/Quality Assurance is an advantage |
| Job Function | Regulatory Affairs |
| Regulatory Authority | US FDA |
Position
Regulatory Affairs Associate II
The selected candidate will prepare and submit regulatory documents within established timelines, maintain regulatory databases and trackers, evaluate post-approval changes, and support compliance with FDA regulations and applicable guidance.
Job Responsibilities
- Maintain approved applications in compliance with FDA regulations for assigned Abbreviated New Drug Application (ANDA) annual reports.
- Request the documentation required for annual reports, compile submissions, and publish them for management review.
- Independently prepare simple regulatory supplements under management direction and submit them for management review.
- Assist management with more complex supplements to gain experience.
- Review applicable FDA post-approval guidance to evaluate change controls accurately.
- Independently evaluate change controls intended for post-approval changes, ensuring completeness and accuracy before consulting the manager or designee.
- Maintain regulatory and team databases and trackers in real time, as directed.
- Train Associate I team members on internal processes, procedures, databases, and trackers when required.
- Perform additional projects and duties as assigned.
Eligibility and Qualifications
Candidates should meet the following requirements:
- Experience: Minimum of four years of pharmaceutical industry experience.
- Preferred experience: Regulatory affairs, analytical functions, quality assurance, laboratory operations, or production.
- Educational advantage: M.Pharm in Regulatory Affairs (RA) or Quality Assurance (QA).
Required Skills
- Basic computer skills, including Microsoft Word and Excel, and familiarity with the internet.
- Ability to work independently and collaboratively in a team.
- Good verbal and written communication skills.
- Strong organizational skills and attention to detail.
- Ability to multitask and manage changing priorities.
- Understanding of applicable FDA regulations and post-approval guidance.
Benefits at Teva India
Teva India lists the following employee benefits and development opportunities:
- Comprehensive medical insurance and OPD coverage.
- Annual health checkups.
- Term life and accident insurance.
- Confidential emotional wellbeing support through the Optum Employee Assistance Program.
- Healthy meals at work and holistic wellbeing initiatives.
- Volunteering programs.
- Learning and development opportunities through the AI-enabled Teva Twist program, R&D Academy, continuing education, and mentorship.
- Opportunities to collaborate on global projects and explore internal career opportunities.
