Regulatory Affairs Associate

Regulatory Affairs Specialist 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

Regulatory Affairs associate I – RA publishing will participate in the publishing of different regulatory activities.  The focus will be to ensure 100% quality and timeline of the submission. This role will be the primary interface with the Regulatory Affairs Associate.

How you’ll spend your day

• Publish and dispatch major and complex routine/lifecycle management eCTD submission projects for EU, US and Canada.
• Exposure in handling post approval submissions publishing and transmitting quality submissions to agency.
• Perform document level publishing activities, troubleshoot document issues and perform quality control checks for submission ready documents as per the agency guidance.
• Collaborate with scientific personnel for planning, preparation and publishing
• Maintain working knowledge of internal and external publishing standards.
• Basic knowledge of ICH and eCTD related specification/guidelines governing regulatory submissions (eCTD, NeeS, paper)
• Must be aware of technical systems like Global Insight, Veeva Vault, ISI Toolbox, Adobe Acrobat, Lorenz Validator

Your experience and qualifications

• B. Pharm/M. Pharm/ Master of Life Sciences.
• Total years of experience required for the role: 1-3 years (if any, preferred Regulatory Publishing experience in EU and US market)
• Command over spoken and written English
• Sensitivity to the cultural diversity of a global organization
• Good understanding of regulatory IT systems

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

Manager – Regulatory Submission Management

Teva’s Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, 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.

Experience Level

Mid Level