Regulatory Affairs Associate III

We Are Teva

We’re Teva, a leading innovative biopharmaceutical company, enabled by a world-class generics business. Whether it’s innovating in the fields of neuroscience and immunology or delivering high-quality medicine worldwide, we’re 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. You'll have the room to grow, the flexibility to balance life with work, and the opportunity to better health worldwide, together.

The opportunity

• The Associate III, with minimal to no guidance, prepares, reviews and submits high quality regulatory submissions to the FDA within company timelines and in accordance with regulatory guidelines.
• The Associate III will be responsible for independently evaluating change controls (intended for post approval changes), will ensure the CC is complete and accurate and in the absence of any comments will progress the CC accordingly.
• In addition, he/she will monitor any/all Regulatory or team databases and trackers and will proactively and accurately update them when changes are required. Annual Reports, supplements, post approval submissions and assisting management with the training of regulatory staff will be the primary responsibilities of Associate III.  

How you’ll spend your day

• Maintain approved applications in compliance with FDA regulations for assigned ANDA Annual reports.
• Independently and proactively request documentation required for annual reports, compile, finalize and publish for managements review and subsequent dispatch to the Agency
• Independently work on supplements, compile and publish for managements review. Take a proactive approach to more complex submissions and contact internal stakeholders (when needed) to gain further insight into any given supplement. Convey findings to management and incorporate any. All applicable information in the submission to ensure quality and a right first-time submission.
• Assist management and proactively train Associate I’s and Associate II’s on guidance’s, internal processes, procedures, databases and trackers 
• Other projects and duties as required/assigned.
• Process improvement

Your experience and qualifications

• Bachelors in pharmacy/master’s in pharmacy/Master in science & Life sciences
• Min 6+ years of Regulatory affairs experience will be preferred in the respective (US) Markets.
• 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 organizational skills and the ability to multi-task, detail oriented.
• Possesses strong critical and logical thinking

How We’ll Take Care of You 

At Teva, better health starts from within, and that includes you. From day one, you’ll 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, you’ll 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, you’ll be part of a culture that empowers you to reach your goals and prioritize your wellbeing every step of the way.

Teva’s Equal Employment Opportunity Commitment