Director, Regulatory Affairs CMC (Small Molecules, Combination Products)

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

As a Director, Regulatory Affairs CMC (Small Molecules, Combination Products) you will:

• Develop regulatory strategies to support development of innovative small molecule and combination products.
• Compile, organize, and assess documents for regulatory submissions to major market health authorities.
• Identify and evaluate CMC issues associated with small molecule development products including product and process development, device development, analytical methods, formulation development, manufacturing, and labeling.
• Lead cross functional product teams for CMC specific projects and contribute to the planning and conduct of meetings with FDA. (development, analytical, quality and manufacturing groups.)
• Develop CMC regulatory strategies for development and post marketing submission activities. Determine and communicate appropriate risk analyses and timeline development.
• Coordinate, author and review the CMC sections of IND, NDA , CTA filings, and internal CMC controlled documentation.
• Perform change management to establish the regulatory impact of changes and ensure compliance of registered commitments.

Qualifications

• Bachelor’s degree in a scientific discipline.
• 8 years of pharmaceutical industry experience.
• 5 years of Regulatory Affairs experience.

Preferred:

• Advanced degree ( M.Sci., Ph.D., PharmD) is preferred.
• Relevant technical experience in Analytical (QC, Analytical R&D), process/product development, or manufacturing is preferred.
• Knowledge of FDA and ICH Regulatory guidelines
• Experience with eCTD regulatory filings
• Knowledge of U.S. and global content and regional requirements
• Knowledgeable in drug development processes and life cycle management of products
• Clear, concise technical writing skills

Function

Sub Function

Reports To

In process of validation

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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.