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 Regulatory Affairs Associate III is responsible for the preparation of high-quality US Gx labeling documents filed under or associated with an ANDA and/or 505(b)2 while ensuring adherence to federal regulations and meeting deadlines driven by company goals.   

Candidate will be required to work independently and possess a strong knowledge of FDA US Gx labeling regulations as well as FDA guidances to the level of applying them effectively to all work output. 

How you’ll spend your day

• Subject Matter Expert in the development, review, and electronic compilation of labeling documents to align with the Reference Listed Drug, company goals, and submission requirements for assigned ANDAs / 505b2s and ensure labeling meets all legal and regulatory requirements.  This includes QC, proofing, editing, and formatting of documents, and coordinating the review and approval of final submission documents as well as preparing full labeling responses to FDA via appropriate filing mode.


• Experience in developing labeling content that requires carve outs due to protected language associated with patent/exclusivities.


• Subject Matter Expert in the development of Structured Product Labeling (SPL) documents (content and data elements) to ensure alignment with associated application as well as applicable FDA regulations and guidances.  This includes QC, proofing, editing, and formatting of applicable sections as well as the data elements section and site establishments, within the SPL software, in addition to troubleshooting any validation error received.


• Work with US Regulatory Labeling Team and Regulatory Operations to ensure assigned projects like RLD updates, Safety labeling changes, Annual reportable changes, Electronic Medication Guide initiatives, etc. and any other projects, as per requirement, are submitted on-time following the eCTD requirements related to labeling.


• Work closely with external departments/sites including IP, Marketing, CMC team(s) and Device team(s) to align with product/device strategy impacting approved portfolio.


• Perform quality reviews of labeling and submission documents as assigned.


• Attend assigned project meetings.


• Serve as back up to Team Lead, as required.


• Assist in the training of lower level colleagues as well as new labeling personnel.


• Assist in the assignment of Reference Listed Drug labeling updates.Maintain knowledge of US regulations, guidelines, databases (Teva and FDA) and standard operating procedures applicable to Gx labeling and drug listing.


• Work in a team environment with minimal supervision.


• Perform all other job related duties as required by management.

Your experience and qualifications

• Msc/MPharm/BPharm with a Scientific or Regulatory background or equivalent combination of education and experience


• Total years of experience required for the role: 6 years


• Relevant years of experience:  6 years (Pharmaceutical industry experience, specifically in Regulatory Affairs with a focus on US Gx labeling)

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. 

Reports To

Senior Manager Regulatory Affairs

Already Working @TEVA?

If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

Teva’s Equal Employment Opportunity Commitment