1+ months

Regulatory Affairs Associate - Regulatory Operations - Submissions Management

Parsippany, NJ 07054
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

Regulatory Affairs Associate - Regulatory Operations / Regulatory Submissions Management

The Regulatory Affairs Associate (Publishing Associate III, Regulatory Submissions Management), is responsible for the publishing and dispatch of major and complex lifecycle management eCTD submissions and ensuring technical validation.  They have proficient 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. Trains junior staff on processes, standards and tools and delegates publishing tasks.

  • 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.
  • Leads and participates in Global Regulatory Affairs project teams

 

Qualifications
  • Bachelors Degree required.
  • Prefer degree in Life Sciences or Information Technology
  • 4 + years in Regulatory Operations / Regulatory Affairs
  • Experience as a publisher for regulatory applications
  • Experience with eCTD technologies, Microsoft Office, Adobe Acrobat, and Documentum.  eCTDXpress or Liquent Insight a plus.
  • Basic understanding of IT infrastructure.
  • Understanding of the drug development process.  Knowledge of generics and branded product development a plus.
  • Proficient knowledge of regulations/guidelines governing regulatory submissions.
  • Working knowledge of industry legislation and best practices.
Function
Regulatory Affairs
Sub Function
Medical Regulatory Affairs
Reports To

Director, North America Regulatory Submissions Management

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.

Categories

Posted: 2019-07-29 Expires: 2019-11-14

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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