Associate II, Sterile, Regulatory Affairs Teva Pharmaceuticals

4.0 - 8.0 years

4 - 7 Lacs

bengaluru

Work from Office

Role & responsibilities With moderate to minimal guidance, prepare, review, and compile new submissions, deficiency responses (IRs, DRLs, CRLs), and amendments using the "Right-First Time" approach. Work with their manager to support early FDA engagement to align on development strategy, reduce regulatory risk, and support first-cycle approvals. Support regulatory assessments and decision-making for significant changes, including site transfers and alternate API sourcing. On occasion, serve as regulatory contact point for cross-functional teams like R&D, QA, Manufacturing & Packaging sites, DMF holders, etc. Monitor and manage regulatory timelines and proactively address data or document gaps. Evaluate and classify change controls for regulatory impact and determine appropriate submission pathways. Compile and submit post-approval changes (PAS, CBE-30, CBE-0, AR) ensuring compliance with FDA, ICH, and internal requirements. Track regulatory guidance updates, stay current with evolving regulatory requirements. Monitor relevant FDA databases (e.g., Drugs@FDA, Orange Book) and ensure internal stakeholders are informed of critical changes. Participate in audits, inspections, and process improvement initiatives. Preferred candidate profile Masters degree in RA/QA discipline, preferably in Pharma. Minimum 4+ years pharmaceutical industry experience with sterile products ; Regulatory, Analytical, QA, laboratory or production experience preferred. Demonstrates an understanding of ICH and FDA guidelines Demonstrates excellent verbal and written communication skills. Demonstrates excellent organization skills and the ability to multi-task; detail oriented. Possesses strong critical and logical thinking.

Posted Date not available

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Associate III, Complex Gx, Regulatory Affairs Teva Pharmaceuticals

6.0 - 11.0 years

6 - 12 Lacs

bengaluru

Work from Office

Role & responsibilities Independently prepare, review, and compile new submissions, deficiency responses (IRs, DRLs, CRLs), and amendments using the "Right-First Time" approach. Support early FDA engagement to align on development strategy, reduce regulatory risk, and support first-cycle approvals. Support regulatory assessments and decision-making for significant changes, including site transfers, formulation modifications, and alternate API sourcing. Lead regulatory discussions with R&D, quality, and manufacturing to resolve data issues and guide regulatory expectations to align on submission readiness and strategies, including global RA alignments. Provide strategic regulatory input and serve as regulatory contact point for cross-functional teams like R&D, QA, Manufacturing & Packaging sites, DMF holders, etc. Monitor and manage regulatory timelines and proactively address data or document gaps. Independently evaluate and classify change controls for regulatory impact and determine appropriate submission pathways. Compile and submit post-approval changes (PAS, CBE-30, CBE-0, AR) ensuring compliance with FDA, ICH, and internal requirements. Mentor and guide junior regulatory staff on compilation, regulatory strategy, and agency communications. Conduct training and share knowledge on updated regulatory requirements and internal best practices. Deputize for Regulatory Manager, including approval of documents, supervising activities, and providing updates to senior leadership. Track regulatory guidance updates, stay current with evolving regulatory requirements. Monitor relevant FDA databases (e.g., Drugs@FDA, Orange Book) and ensure internal stakeholders are informed of critical changes. Participate in audits, inspections, and process improvement initiatives. Preferred candidate profile Masters degree in RA/QA discipline, a plus. Minimum 7+ years of RA experience in which 4 to 5 years pharmaceutical industry experience with semi-solid, transdermal, and nasal spray complex generic products ; Demonstrates an understanding of ICH and FDA guidelines Demonstrates the ability to evaluate regulatory documents and determine appropriate action. Demonstrates excellent verbal and written communication skills. Demonstrates excellent organization skills and the ability to multi-task; detail oriented. Possesses strong critical and logical thinking.

Posted Date not available

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