1+ months

Regulatory Affairs Associate - Regulatory Operations - Submissions Management

Parsippany, NJ 07054
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Company Info
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

The Regulatory Affairs Associate (Publishing Associate II, Regulatory Submissions Management), is 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.

  • Publish and dispatch 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
  • Identifies when data seems incorrect, incomplete or needs verification. Understands the business benefit and risk to steps being performed. Understands why steps are taken and can relate them to business objective.
  • Performs tasks with care; is thorough. Makes few if any errors. Checks work to ensure accuracy and completeness.
  • Sees existing problems/process inefficiencies and has novel approaches to solving those problems. Contributes original and resourceful ideas in brainstorming sessions.
  • Can describe customers business and expectations. Shows interest in, anticipates, and responds timely to customer needs.

Required: Bachelor's degree

Preferred: Bachelors Degree in Life Sciences or Information Technology

Experience Required: 2 +  years in Regulatory Operations/Regulatory Affairs

Experience Preferred: Experience as a publisher for regulatory applications

  • Experience with eCTD technologies, Microsoft Office, Adobe Acrobat.  Liquent Insight a plus.
  • 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.
  • Knowledge of regulations/guidelines governing regulatory submissions
Regulatory Affairs
Sub Function
Medical Regulatory Affairs
Reports To

Director, NA Reg Submissions Mgmt

Tevas 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.

Posted: 2019-07-29 Expires: 2019-12-04

Join us at the forefront of pharmaceutical research and production. With state-of-the-art facilities, highly skilled colleagues, and a high-powered organizational culture, Teva offers you countless possibilities to make a real difference in people's lives and add value to your career.

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Regulatory Affairs Associate - Regulatory Operations - Submissions Management

Teva Pharmaceuticals
Parsippany, NJ 07054

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