Job Title: Regulatory Affairs Associate III

About Teva

Teva is a global pharmaceutical leader and the world’s largest producer of generic medicines. We are dedicated to improving health and expanding access to quality healthcare solutions worldwide.

The Opportunity

We are seeking a Regulatory Affairs Associate III to lead and manage regulatory submissions and post-approval activities with Health Canada (HC). This role involves preparing, reviewing, and submitting high-quality applications, ensuring compliance with regulatory standards, and supporting cross-functional teams for timely product approvals.

Key Responsibilities

• Prepare, compile, review, and submit post-approval regulatory submissions in line with HC regulations and corporate standards.

• Develop and implement regulatory strategies for assigned projects through approval and launch.

• Collaborate with R&D and other business functions to ensure regulatory requirements are met on time.

• Evaluate change controls for filing assessments per HC guidance and manage post-approval activities accordingly.

• Stay updated on Teva procedures, HC regulations/guidelines, and ICH requirements.

• Provide input for business development assessments when required.

• Perform other regulatory projects and duties as assigned.

Candidate Profile

• M.Pharm degree in a relevant scientific discipline.

• 5–7 years of regulatory affairs experience in post-approval (preferably Health Canada; EU/FDA experience considered).

• Overall 7–10 years of pharmaceutical industry experience.

• Prior experience with sterile products preferred.

• Strong oral and written communication skills.

• Excellent organizational ability, attention to detail, and multitasking skills.

• Demonstrates critical and logical thinking.

Role Details

• Job ID: 63515

• Experience Required: 5–7 years (Regulatory Affairs); 7–10 years (Pharma industry)

• Qualification: M.Pharm

• Location: Bangalore

• Industry Type: Pharma / Healthcare / Clinical Research

• Functional Area: Regulatory Affairs

• Application End Date: 31st August 2025

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