Regulatory Affairs Associate II

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 II, with moderate to minimal guidance, prepares, reviews and submits high quality regulatory submissions to the FDA within company timelines and in accordance with regulatory guidelines.
• The Associate II will be responsible for independently evaluating change controls (intended for post approval changes), will ensure the CC is complete and accurate and will consult his/her manager/designee prior to progressing the CC.
• In addition, he/she will accurately populate and maintain any/all Regulatory or team databases and trackers in real time, as directed by their manager or Designee. Annual reports, supplements and post approval submissions will be the primary responsibilities of Associate II.

How you’ll spend your day

• Maintain approved applications in compliance with FDA regulations for assigned ANDA Annual reports.  
• Under minimal supervision, proactively request documentation required for annual reports, compile and publish for managements review.
• Under management’s direction/assignment, work independently on simple supplements, compile and publish for managements review. Assist management on more complex supplement to gain experience.   
• Further educate oneself on FDA Regulations by reviewing any/all applicable post approval guidance’s to understand and accurately assess change controls.   
• When needed, train Associate I’s on internal processes, procedures, databases and trackers.
• Other projects and duties as required/assigned

Your experience and qualifications

• M. Pharma degree in RA/QA discipline, a plus.
• Minimum four years plus pharmaceutical industry experience; Regulatory, Analytical, QA, laboratory or production experience preferred.
• Basic computer skills such as Word, Excel and familiarity with the internet
• Ability to work independently and on teams
• Good verbal and written communication skills
• Must be well organized, detail oriented, have the ability to multi-task and manage changing priorities

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