Regulatory Affairs Associate I

Who are we?

Teva is a global pharmaceutical leader and the world's largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world's largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we've built a promising pipeline centered around our core therapeutic areas. We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth!

Job Description

Publishing Associate I, Regulatory Submissions Management
Full-time, permanent
Scarborough, Ontario (Hybrid)

The Publishing 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.

Tasks and responsibilities will include but are not limited:

• Publish and dispatch major and complex routine/lifecycle management eCTD submission projects
• Perform document level publishing activities, troubleshoot document issues and perform quality control checks for submission ready documents
• Collaborate with scientific personnel for planning, preparation, publishing and quality control checks of submissions.
• Participate in Global Regulatory Affairs project teams
• 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

Qualifications

• Bachelor’s Degree in relevant field. Preferred: Bachelor’s Degree in Life Sciences or Information Technology
• 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)

Function

Sub Function

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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.