Job Opportunity: Regulatory Affairs Associate at Teva Pharmaceuticals

Job Summary
Teva Pharmaceuticals is seeking a detail-oriented and experienced Regulatory Affairs Associate to join our team in Navi Mumbai. This is a full-time, hybrid position ideal for professionals with 2–4 years of experience in regulatory publishing and eCTD submissions. The successful candidate will play a pivotal role in managing global submissions, ensuring compliance with international regulatory standards, and supporting the lifecycle management of our diverse pharmaceutical portfolio.

Job Overview

• Position: Regulatory Affairs Associate
• Company: Teva Pharmaceuticals
• Location: Navi Mumbai, Maharashtra
• Work Mode: Hybrid
• Job Type: Full-Time
• Experience Required: 2–4 Years
• Education: B.Pharm / M.Pharm / MSc (Life Sciences)

Responsibilities

As a Regulatory Affairs Associate, you will be responsible for the preparation and management of complex regulatory submissions. Your primary duties will include:

• Submission Management: Prepare, publish, and dispatch high-quality eCTD submissions for regulatory agencies in the US, EU, and Canada.
• Lifecycle Maintenance: Manage post-approval submissions and ongoing lifecycle activities to ensure products remain in compliance with regulatory requirements.
• Quality Assurance: Perform document-level publishing and rigorous quality control (QC) checks to ensure all materials meet strict regulatory guidelines.
• Technical Troubleshooting: Proactively identify and resolve submission-related issues, ensuring that all documentation is “submission-ready.”
• Cross-Functional Collaboration: Partner with scientific and technical teams to plan and execute publishing timelines effectively.
• Regulatory Compliance: Maintain an up-to-date knowledge of ICH guidelines, eCTD/NeeS formats, and evolving global regulatory standards.
• Tool Utilization: Efficiently utilize industry-standard publishing software, including Veeva Vault, Global Insight, ISI Toolbox, Lorenz Validator, and Adobe Acrobat.

Requirements

To be successful in this role, you must possess the following qualifications and skills:

• Educational Background: A degree in B.Pharm, M.Pharm, or MSc in Life Sciences.
• Professional Experience: 2–4 years of hands-on experience specifically in Regulatory Affairs or Regulatory Publishing.
• Technical Expertise: Proficiency in eCTD submissions, particularly for the US and EU markets.
• Regulatory Knowledge: A solid understanding of ICH guidelines and general global regulatory frameworks.
• Tool Proficiency: Practical experience with regulatory publishing tools such as Veeva Vault, Lorenz, or similar systems is essential.
• Soft Skills: Strong attention to detail, excellent organizational abilities, and the capacity to work collaboratively within a global, fast-paced environment.

Why Join Teva Pharmaceuticals?

Teva Pharmaceuticals is a global leader in the pharmaceutical industry. By joining our team, you will:

• Work at the forefront of global drug development and regulatory compliance.
• Gain exposure to complex international markets including the US, EU, and Canada.
• Benefit from a hybrid work environment that supports a healthy work-life balance.
• Access opportunities for professional growth in a highly specialized field, enhancing your skills in global submission strategies and lifecycle management.

Salary and Compensation

The estimated salary range for this position is ₹5.5 LPA – ₹9 LPA. Final compensation will be commensurate with the candidate’s experience, technical proficiency, and interview performance, in alignment with industry standards for regulatory affairs roles in India.

How to Apply

If you meet the requirements and are interested in advancing your career with Teva Pharmaceuticals, please submit your updated resume and cover letter via the official Teva Careers portal or the designated company application link. Ensure that your application highlights your experience with eCTD publishing tools and specific regulatory market exposure.

Teva Pharmaceuticals is an equal opportunity employer and welcomes applications from qualified professionals.