Regulatory Affairs Associate I

Who we are

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 I, Regulatory Submissions Management, is responsible for responsible for the publishing and dispatch of basic and complex lifecycle management eCTD submissions and ensuring technical validation. They have a working knowledge of internal/external publishing standards, electronic publishing/viewing software tools and document management systems. Independently performs document level publishing activities, troubleshoots document issues and performs quality control checks for submission ready documents. 

How you’ll spend your day

Essential Duties / Functions:
1.    Publish and dispatch major and complex routine/lifecycle management eCTD submission projects    
2.    Perform document level publishing activities, troubleshoot document issues and perform quality control checks for submission ready documents    
3.    Collaborate with scientific personnel for planning, preparation, publishing and quality control checks of submissions.    
4.     Participate in Global Regulatory Affairs project teams   
5.    Maintain working knowledge of internal and external publishing standards    

Follows Teva Safety, Health, and Environmental policies and procedures
Other projects and duties as required/assigned

Your experience and qualifications

Any equivalent combination of education, training, and/or experience that fulfills the requirements of the position will be considered.

Education Required:    Bachelor’s Degree     Preferred:    Bachelor’s Degree in Life Sciences or Information Technology

Experience required:
0-2  years in Regulatory Operations/Regulatory Affairs     
Preferred:    Experience as a publisher for regulatory applications

•    Experience with Liquent InSight suite, Microsoft Office suite, Adobe, Documentum, and eCTD technology 
•    Basic understanding of IT infrastructure 
•    Understanding of the drug development process.  Knowledge of generics and branded product development a plus
•    Working knowledge of industry legislation and best practices
•    Strong knowledge of regulations/guidelines governing regulatory submissions (eCTD, NeeS, paper)

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. 

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

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, genetic information, marital status, sexual orientation, gender identity or expression, ancestry, national or ethnic origin, citizenship status, military status or status as a disabled or protected veteran, or any legally recognized status entitled to protection under applicable federal, state, or local laws.   

Please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience. Request a reasonable accommodation by sending an email to disabilityassistance@tevapharm.com with the nature of your request and your contact information. Only inquiries concerning a request for a reasonable accommodation will be responded to from this email address.  

Important notice to Employment Agencies - Please Read Carefully  

Teva Pharmaceuticals USA does not accept unsolicited assistance from agencies for employment opportunities.  All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.