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Associate II, Complex Gx, Regulatory Affairs

Associate II, Complex Gx, Regulatory Affairs

Teva Pharmaceuticals

4 - 8 years

0 Lacs

bangalore karnataka

Posted:1 week ago| Platform: Shine logo

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Skills Required

regulatory affairs regulatory submissions process improvement initiatives organization skills critical thinking fda regulations ich guidelines pharmaceutical industry experience inhalation products implant products ophthalmic products drugdevice combination products change controls regulatory pathways postapproval supplements verbal written communication skills multitasking

Work Mode

On-site

Job Type

Full Time

Job Description

As an Associate II in Complex Gx, Regulatory Affairs at Teva Pharmaceuticals, you will be responsible for the preparation and submission of high-quality regulatory filings for U.S. FDA-regulated inhalation, implant, ophthalmic, and drug-device combination complex generic products. Your role will involve managing regulatory submissions, collaborating with cross-functional teams, evaluating change controls, and submitting post-approval supplements in accordance with FDA guidelines and internal SOPs. Additionally, you may serve as a regulatory point of contact for assigned products and contribute to process improvement initiatives. Key Responsibilities: - Prepare, review, and compile new submissions, deficiency responses, and amendments following the "Right-First Time" approach. - Support early FDA engagement to align on development strategy, reduce regulatory risk, and support first-cycle approvals. - Assist in regulatory assessments and decision-making for significant changes. - Serve as a regulatory contact point for cross-functional teams. - Monitor and manage regulatory timelines, address data/document gaps, and evaluate change controls for regulatory impact. - Compile and submit post-approval changes ensuring compliance with FDA, ICH, and internal requirements. - Stay updated with evolving regulatory requirements, FDA databases, and communicate critical changes to internal stakeholders. - Participate in audits, inspections, and process improvement initiatives. Qualifications: - Masters degree in RA/QA discipline, preferably in Pharma. - Minimum 4+ years of pharmaceutical industry experience with relevant products. - Understanding of ICH and FDA guidelines. - Excellent verbal and written communication skills. - Strong organization skills, ability to multitask, detail-oriented, and possess critical thinking abilities. At Teva Pharmaceuticals, we are on a mission to make good health more affordable and accessible, impacting millions of lives worldwide. Join us in our pursuit to continue making a difference in the healthcare industry. Apply now to be part of our diverse and innovative team.,

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Teva Pharmaceuticals

Pharmaceutical Manufacturing

Tel-Aviv Petach Tikva

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Associate II, Complex Gx, Regulatory Affairs

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bangalore, karnataka

Associate II, Complex Gx, Regulatory Affairs

Teva Pharmaceuticals

bangalore, karnataka

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Associate II, Complex Gx, Regulatory Affairs