30 days old

Manager Regulatory Affairs

West Chester, PA 19380
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
 
 

 

Manager Regulatory Affairs will be responsible for supporting the Global Regulatory Lead (GRL) in strategic vision and innovative scientific and regulatory leadership in defining the global regulatory strategy for biosimilar projects.

 

  • Support the Global Regulatory Affairs Team for assigned projects to ensure alignment of the regional, clinical and CMC regulatory strategies with the overall global strategy.
  • Will have responsibility for assisting the GRL in ensuring collaboration with key internal stakeholders of the Core Project Team (CPT), Clinical Development Team (CDT), and Chemistry Manufacturing and Controls Team (CMC) to ensure successful planning and execution of the global regulatory strategy for assigned projects.
  • Assist in the delivery of successful regulatory license applications and product life cycle management submissions with the Global Regulatory Affairs Team.
  • Support the regional strategic leads on the establishment and maintenance of high quality working relationships with the FDA, EMA, PMDA and other global regulatory agencies as appropriate for assigned products.
  • Responsible to assist the GRL for regulatory strategic decision making necessary to ensure planning and execution of successful global regulatory strategies, submissions and approvals for assigned biosimilar project(s).
  • Will be nterfacing with regulatory agencies and proven skill at developing and implementing successful global regulatory strategies

Experience:

  • Minimum of 7 plus  years of experience in the biotech or pharmaceutical industry, with at least 5 years in Regulatory with 2plus years of that time in a commercial stage organization.
  • Experience in leading and managing matrix teams (Minimum 2 plus years' of experience)
  • Knowledge and understanding of pharmaceutical/biological/biosimilar product development and regulatory requirements for product development and approval in more than one key   region (EU, US, Japan) as well as life cycle management of products
  • Experience working in Regulatory Affairs in a global environment across two or more geographic areas
  • Clinical, CMC and biosimilar foundation.  Experience or background in sterile/parenteral products and drug/device combination products is preferred
  • Experience populating and maintaining databases (i.e., Trackwise) working in Electronic Document Management Systems and trackers (i.e., Excel)
  • Experience in evaluating Change Requests/Change Controls for regulatory documents and providing accurate regulatory assessments
     

Education:

Bachelors degree in pharmacy, biology, chemistry, or related life science is required

Categories

Posted: 2020-08-25 Expires: 2020-10-22

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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Manager Regulatory Affairs

Teva Pharmaceuticals
West Chester, PA 19380

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