Regulatory Affairs Associate I

Teva Pharmaceuticals•West Chester, IA

About The Position

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 opportunityThe 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 dayEssential 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 proceduresOther projects and duties as required/assignedYour experience and qualificationsAny equivalent combination of education, training, and/or experience that fulfills the requirements of the position will be considered.

Requirements

Bachelor’s Degree
0-2 years in Regulatory Operations/Regulatory Affairs
Experience with Liquent InSight suite, Microsoft Office suite, Adobe, Documentum, and eCTD technology
Basic understanding of IT infrastructure
Understanding of the drug development process.
Working knowledge of industry legislation and best practices
Strong knowledge of regulations/guidelines governing regulatory submissions (eCTD, NeeS, paper)

Nice To Haves

Bachelor’s Degree in Life Sciences or Information Technology
Experience as a publisher for regulatory applications
Knowledge of generics and branded product development a plus

Responsibilities

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