Are you an experienced Regulatory Affairs professional looking to work with a global pharmaceutical leader?  Teva Pharmaceuticals⁠ is hiring for the position of Regulatory Affairs Associate II in Navi Mumbai, India. This is an excellent opportunity for candidates with experience in regulatory submissions, post-approval changes, and FDA compliance to build a rewarding career in the pharmaceutical industry.

Job Overview

Position: Regulatory Affairs Associate II
Company: Teva Pharmaceuticals
Location: Navi Mumbai, Maharashtra, India – 400706
Job ID: 68002
Experience Required: 4+ Years
Qualification: M.Pharm (Regulatory Affairs/Quality Assurance preferred)

About Teva Pharmaceuticals

Teva Pharmaceuticals is one of the world’s leading pharmaceutical companies, delivering high-quality medicines and improving healthcare globally. The company combines innovation with a strong generics business to address patients’ evolving healthcare needs.

Teva fosters an inclusive work culture focused on innovation, collaboration, and employee growth while making a meaningful impact on global healthcare.

Key Responsibilities

As a Regulatory Affairs Associate II, you will:

• Prepare, review, and submit high-quality regulatory submissions to the FDA.
• Independently evaluate change controls related to post-approval changes.
• Ensure completeness and accuracy of change control documentation.
• Maintain regulatory databases and trackers in real time.
• Prepare annual reports, supplements, and post-approval submissions.
• Work closely with managers and designated teams to ensure regulatory compliance.
• Support management review activities and complex regulatory supplements.
• Train junior associates on procedures, databases, and trackers when required.
• Stay updated with FDA regulations and post-approval guidance documents.

Daily Activities

Your typical workday may include:

• Maintaining approved applications in compliance with FDA regulations.
• Preparing annual reports and documentation packages.
• Reviewing regulatory submissions and supplements.
• Managing databases and regulatory trackers.
• Coordinating with cross-functional teams.
• Supporting continuous improvement and compliance initiatives.

Eligibility Criteria

Candidates should possess:

• M.Pharm degree in Regulatory Affairs, Quality Assurance, or related discipline.
• Minimum 4 years of pharmaceutical industry experience.
• Experience in Regulatory Affairs, Analytical, QA, Laboratory, or Production functions.
• Proficiency in MS Word, Excel, and internet applications.
• Strong written and verbal communication skills.
• Ability to work independently and manage multiple priorities effectively.

Why Join Teva?

Joining Teva offers several advantages:

• Purpose-driven work impacting millions of lives globally.
• Inclusive and collaborative workplace culture.
• Global career growth opportunities.
• Work-life balance and employee-friendly policies.
• Learning and development programs.
• International exposure within a world-class pharmaceutical organization.

Employee Benefits

Teva provides comprehensive benefits including:

• Medical insurance coverage and annual health checkups.
• Term life and accident insurance.
• Employee assistance and wellbeing programs.
• Healthy workplace initiatives.
• Volunteer opportunities for community engagement.
• Continuous learning through internal academies and mentorship programs.

How to Apply?

Interested candidates can apply through the official Teva careers portal or submit their resume through the application channel mentioned in the recruitment post.

Visit the official careers page:
Teva Careers⁠