Regulatory Affairs Associate - Publishing

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. You'll have the room to grow, the flexibility to balance life with work, and the opportunity to better health worldwide, together.

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

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)

Your Experience And Qualifications

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

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.  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. Manager – Regulatory Submission Management

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. 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.

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.