Regulatory Affairs Associate III

We Are Teva

Were Teva, a leading innovative biopharmaceutical company, enabled by a world-class generics business. Whether its innovating in the fields of neuroscience and immunology or delivering high-quality medicine worldwide, were dedicated to addressing patients needs now and in the future. Here, you will be part of a high-performing, inclusive culture that values fresh thinking and collaboration. Youll have the room to grow, the flexibility to balance life with work, and the opportunity to better health worldwide, together.

The opportunity

• The Associate II, Complex Gx, Regulatory Affairs is responsible for the preparation and submission of high-quality regulatory filings-both pre- and post-approval-for U.S. FDA-regulated inhalation, implant, ophthalmic, and drug-device combination complex generic products. With moderate to minimal guidance, the Associate II will manage regulatory submissions-including original applications, amendments, deficiency responses, and postapproval supplements-while collaborating closely with cross-functional teams.
• The role includes evaluating change controls, determining appropriate regulatory pathways (e.g., PAS, CBE-30, CBE-0, AR), confirming the change assessment with their regulatory manager, and submitting post-approval supplements in accordance with FDA guidelines and internal SOPs.
• The Associate II, on occasion, will also serve as a regulatory point of contact for assigned products and contribute to process improvement initiatives

How youll spend your day

• 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, formulation modifications, 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.

Your experience and qualifications

• Masters degree in RA/QA discipline, preferably in Pharma.
• Minimum 4+ years pharmaceutical industry experiencewith inhalation, implant, ophthalmic, and drug-device combination productsRegulatory, 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.

How Well Take Care of You

At Teva, better health starts from within, and that includes you. From day one, youll be supported with benefits designed to help you thrive in and out of work. This includes generous annual leave, reward plans, flexible working schedules (dependent on role), access to tailored health support, and meaningful ways to give back to the community. When it comes to your career, youll be encouraged to explore, evolve, and shape your path. Twist, our one-stop shop for career development platform, gives you access to a wide range of possibilities, from learning programs and short-term projects to opportunities for internal growth. Here, youll be part of a culture that empowers you to reach your goals and prioritize your wellbeing every step of the way.

Tevas Equal Employment Opportunity Commitment