Regulatory Affairs Associate Iii Job in Teva Pharmaceutical Industries Ltd.

Regulatory Affairs Associate Iii

Teva Pharmaceutical Industries Ltd. 4+ weeks ago

Mumbai, Maharashtra
Not Disclosed
Full-time
Permanent

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Job Summary Company InfoTeva is a global pharmaceutical leader and the world's largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world's largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we've built a promising pipeline centered around our core therapeutic areas. We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth!Job Description

Will be working closely with third party for getting documents for compilation of new ANDAs filings and deficiencies responses. Will have to ensure for new requirements for submission of ANDAs as per US regulatory guidelines. Filing the right first high quality standards ANDA will be key responsibility to get ANDAs approved in first review cycle.
Review, approve and compile regulatory submission documents for new ANDA and DL responses. Should be guiding development team on regulatory requirements for right first time approach for high quality ANDAs. Putting forward regulatory strategies for new projects during development phase of products in collaboration with third party R&D. Review of analytical & formulation documents and ensure for high quality document for product submissions meeting the US regulatory requirements.
Timely review of documents (e.g. Master Manufacturing Formula, Product Development Reports, Specifications, Stability protocols, Comparative dissolution profiles etc) for new ANDA submission.
Assessments IIG, Bio-waiver, Elemental Iron content intake, Elemental Impurity assessment reports, and Residual solvents assessment reports etc. and regulatory review of new formulations strategies.
Ensure for risk mitigation strategies and no RTR issues are there right from development phase of products.
Compilation of high quality standards CMC sections for new ANDAs and DL responses.

Qualifications

MPharm / BPharm with 8-10 Yrs experience in US Regulatory Experience.

FunctionRegulatory AffairsSub FunctionMedical Regulatory AffairsAlready Working @TEVA?

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Experience Required :

Fresher

Vacancy :

2 - 4 Hires