Sr Manager Regulatory Affairs - US Labeling Teva Pharmaceuticals

8.0 - 10.0 years

0 Lacs

bengaluru, karnataka, india

On-site

The Opportunity: The Senior Manager is responsible for setting strategic goals, managing, leading and developing teams, driving operational efficiency, and making high-level decisions that affect the teams success. In addition, will be responsible for the supervision, critical review, & approval of established US Gx labeling documents filed under an ANDA/505(b)2s while adhering to federal regulations, internal processes, & meeting timelines driven by company goals. Additionally, the Sr. Manager will oversee any/all team databases and trackers. The candidate must possess a firm knowledge of FDA US labeling regulations & guidance for products filed under an ANDA/505(b)2 and should be a SME in ...

Posted 3 weeks ago

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Mgr Regulatory Affairs, Labeling Teva Pharmaceuticals

6.0 - 10.0 years

0 Lacs

karnataka

On-site

The Manager of Regulatory Affairs, Labeling at Teva Pharmaceuticals is responsible for supervising, critically reviewing, and approving established US Gx labeling documents filed under an ANDA/505(b)(2) by team members in the US and Mumbai/Bangalore locations. The Manager must ensure compliance with federal regulations, internal processes, and company goals while meeting established timelines. Additionally, they will oversee team databases and trackers, updating them as needed. The ideal candidate should have a strong understanding of FDA US labeling regulations and guidances for products filed under an ANDA/505(b)(2) and be a Subject Matter Expert in US labeling, including SPL, PADERs, and ...

Posted 2 months ago

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Regulatory Affairs Manager Teva Pharmaceuticals

8.0 - 10.0 years

0 Lacs

Bengaluru, Karnataka, India

On-site

The Opportunity: The Manager is responsible for the supervision, critical review, and approval of established US Gx labeling documents filed under an ANDA/505(b)(2) by US and Mumbai/Bangalore (India locations) members while adhering to federal regulations, internal processes, and meeting timelines driven by company goals. The Manager will also be responsible for their own assignments, when needed, and working closely with other Managers surrounding the review and approval of labeling documents established for these projects. Additionally, the Manager will oversee all team databases and trackers and will update them when changes are required. The candidate must possess a firm knowledge of FDA...

Posted 3 months ago

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