Teva Pharmaceuticals Hiring Regulatory Affairs II

Teva Pharma Regulatory Affairs II | Navi Mumbai

Teva Pharmaceuticals invites M.Pharm professionals for Regulatory Affairs II in Navi Mumbai. 4+ yrs experience in FDA-compliant ANDA required.

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Teva Pharmaceuticals, a global leader in generic and specialty medicines, is seeking a Regulatory Affairs II professional to join its Navi Mumbai team. This role offers a unique opportunity to manage FDA-compliant ANDA applications and contribute to ensuring regulatory excellence in post-approval processes.

Company Overview

Teva Pharmaceuticals is renowned worldwide for its innovative approach to developing affordable medicines. With a strong portfolio spanning generic and specialty products, Teva focuses on quality, compliance, and research-driven healthcare solutions. Joining Teva offers professionals exposure to a highly regulated, internationally recognized pharmaceutical environment, enabling growth in regulatory, quality, and operational expertise.

Job Role & Responsibilities

Regulatory Affairs II – Key Responsibilities

• Maintain approved ANDA applications in compliance with FDA regulations, focusing on Annual Reports.
• Independently compile and publish simple supplements.
• Assist in preparing complex supplements under guidance.
• Proactively gather documentation to support regulatory submissions.
• Train Associate I staff on internal regulatory processes and tools.
• Stay abreast of FDA regulations, post-approval guidance, and industry updates.
• Ensure timely and accurate submission of regulatory documents to maintain compliance.

Eligibility / Qualifications

• Qualification: M. Pharm in Regulatory Affairs or Quality Assurance preferred.
• Experience: Minimum 4+ years in Regulatory Affairs, QA, Analytical, or Production roles within the pharmaceutical industry.
• Skills: Strong understanding of FDA regulations, ANDA applications, and post-approval compliance.

Relevant Courses: Regulatory Affairs, Quality Assurance, Pharmaceutical Sciences, Drug Development, FDA Compliance, ANDA Management, Post-Approval Processes.

Location & Salary

• Location: Navi Mumbai, Maharashtra
• Salary: Competitive, aligned with industry standards and candidate experience.

Application Process

Interested candidates can apply by sending their resumes to: apeksha.shinde01@teva.co.in

Act promptly to secure your position at Teva Pharmaceuticals and advance your regulatory affairs career in the pharma industry!

FAQs

Q1: What is the minimum experience required?
Candidates must have at least 4 years of relevant experience in Regulatory, QA, Analytical, or Production roles.

Q2: Is M.Pharm mandatory for this position?
M.Pharm in Regulatory Affairs or QA is preferred; candidates with equivalent experience may also be considered.

Q3: What regulatory expertise is expected?
Experience managing FDA-compliant ANDA applications and familiarity with post-approval guidance.

Q4: Can freshers apply?
No, this role requires 4+ years of professional experience.

Q5: What is the work location?
This position is based in Navi Mumbai, Maharashtra.

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Job Summary Table

Category	Details
Company	Teva Pharmaceuticals
Vacancies	Regulatory Affairs II
Required Education	M.Pharm (Regulatory Affairs/QA preferred)
Experience	4+ years in Regulatory, QA, Analytical, or Production

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