1+ months

Senior Director, Regulatory Affairs

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!

 

We offer a competitive benefits package including Medical, Dental, Vision, and Prescription coverage starting on the first day.  We also offer Disability and Life Insurance, Paid Time Off, 6% match on the 401(k), Employee Stock Purchase Plan and Tuition Assistance. For more information on Teva, check us out at www.tevapharm.com or www.tevausa.com

The Senior Director, Regulatory Affairs is responsible for leading Tevas US Generics Steriles team in the development, submission and management of sterile, complex and combination product applications, resulting in timely FDA approvals in accord with Tevas goals.  Also responsible for leading the team in maintenance of Tevas existing sterile products portfolio. Will work closely with the VP, Regulatory Affairs- develops regulatory initiatives and strategies for the sterile portfolio, including complex and combination products to ensure goals are achieved, while maintaining compliance with all FDA regulations. 

 

 

  • Primary FDA contact on behalf of Teva USA for all of Tevas sterile generic products, including complex and combination products.  
  • Support the VP, Regulatory Affairs in developing strategies for sterile products including complex and combination products.
  • Take the lead on many regulatory initiatives involving widespread operations or policy changes.
  • Review outgoing FDA correspondence (ANDAs, NDAs, amendments, supplements) for completeness and correctness, with a goal of right first time submission that will lead to first cycle approvals.
  • Develop and communicate regulatory strategies to internal customers and third party partners.
  • Supervise and develop a team, including several direct reports; conduct performance evaluations, etc.
     

Experience Required and Preferred:

 

  • Minimum 12 plus  years in pharmaceutical regulatory affairs with proven track record of interacting with health authorities, and demonstration of thorough understanding of requirements related to sterile products including complex and combination products.   
  • 8 years in a supervisory position

 

Education Required: 

  • Bachelor of Science degree in scientific or healthcare discipline, or equivalent combination of education and related experience.

 

Education Preferred;

  • R.Ph., Pharm.D., M.S., Ph.D., or equivalent combination of education and related experience.

 

Specialized or Technical Knowledge Licenses, Certifications needed: 

  • R.Ph. and/or RAC certification is beneficial, but not mandatory. ANDA submission and approval requirements, working knowledge of chemistry, manufacturing and controls as needed for ANDA submissions.

 

Categories

Posted: 2020-08-26 Expires: 2020-10-16

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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Senior Director, Regulatory Affairs

Teva Pharmaceuticals
Parsippany, NJ 07054

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