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Teva Pharmaceuticals
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Mgr Regulatory Affairs, Labeling

Mgr Regulatory Affairs, Labeling

Teva Pharmaceuticals

8 - 12 years

0 Lacs

bangalore karnataka

Posted:3 weeks ago| Platform: Shine logo

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Skills Required

regulatory affairs anda spl regulatory operations labeling fda regulations sopswis

Work Mode

On-site

Job Type

Full Time

Job Description

As a Manager Regulatory Affairs, Labeling at Teva Pharmaceuticals, you will be responsible for setting strategic goals, managing and leading teams, driving operational efficiency, and making high-level decisions that impact the team's success. You will supervise, critically review, and approve established US Gx labeling documents filed under an ANDA/505(b)2s while ensuring compliance with federal regulations, internal processes, and meeting timelines aligned with company goals. Additionally, you will oversee team databases and trackers to ensure projects remain on track. Key Responsibilities: - Establish and implement labeling strategies for all US generic product ANDAs/505(b)2s, both pre and post-approval - Ensure compliance with all FDA reporting obligations according to business objectives and regulations - Provide guidance on best practices in the labeling arena - Lead daily workload activities and assign labeling projects - Develop, review, and compile labeling documents in alignment with RLD, FDA safety changes, company initiatives, and submission requirements - Maintain labeling trackers and ensure project timelines are met - Expertise in Structured Product Labeling (SPL) to align with FDA regulations and guidances - Collaborate with Regulatory Operations to meet submission deadlines following eCTD requirements - Coordinate with external departments to align with product strategy for pre and post-approval portfolio - Attend relevant meetings and create/revise SOPs/WIs as needed - Stay updated on US regulations, guidelines, and SOPs/WIs related to US Gx labeling - Experience in developing labeling content requiring carve outs due to protected language associated with patent/exclusivities is preferred Qualifications Required: - MPharm/BPharm with a Scientific or Regulatory background or equivalent - Minimum 8 years of US labeling experience and at least 3 years of supervisory experience preferred - Minimum 8 years of Pharmaceutical industry experience, specifically in Regulatory Affairs & US ANDA/505(b)(2) labeling As a part of Teva Pharmaceuticals, you will contribute to the mission of making good health more affordable and accessible to help millions around the world enjoy healthier lives. With a diverse workforce spread across nearly 60 countries, you will have the opportunity to work with the world's leading manufacturer of generic medicines and play a vital role in improving global healthcare. Apply now to be a part of our mission and make a difference!,

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Teva Pharmaceuticals

Pharmaceutical Manufacturing

Tel-Aviv Petach Tikva

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Mgr Regulatory Affairs, Labeling