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Senior Director Regulatory Affairs

Date: Nov 24, 2021

Location: West Chester, Pennsylvania, US, 19380

Company: Teva Pharmaceuticals

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

As the Sr. Director, Regulatory Affairs you will be responsible for the development, coordination and implementation of regulatory strategies within the Neuroscience Therapeutic Area. You will provide the regulatory strategic leadership and support for early and/or late stage development programs as well as marketed products.

 

Working within Teva Specialty Products, this role will provide oversight of the global registration strategies to obtain marketing approval in focus countries as well as expanding into new indications with approved products. 

 

As a leader within a global regulatory team, you will develop/coordinate/implement regulatory strategy as a valued member of a multi-disciplinary project team for branded products. Take responsibility for ensuring timely development of a comprehensive regulatory strategy and operating plans. Regularly report to management on progress against objectives. Plan and direct projects and provide technical background, inspiration, leadership, and consultation to cross-functional colleagues as well as members of the global regulatory project team.

 

Other duties:

  • Coordinate and effectively lead the project team in planning, preparation, and execution (lead facilitator) of meetings or teleconferences with Health Authorities (e.g., FDA, EMA).  Capably negotiates issues of strategic importance.
  • Lead the internal activities of review teams, and facilitate approval of regulatory submissions including coordination of appropriate responses to Health Authorities with relevant personnel and departments to resolve outstanding regulatory issues.
  • Identify regulatory risks and opportunities including pathways for expedited development. Serve as the regulatory representative on project teams with active involvement in writing and review of global regulatory submissions. 
  • Provide training and mentorship to regulatory staff. Independently develop Regulatory Intelligence to support above activities.  Leads due diligence for assigned global branded products.
  • Identify opportunities to optimize business processes and systems across the Specialty Regulatory organization. 
  • Manage other regulatory strategists and provide mentorship and leadership towards their development
     

Qualifications

What you will bring to the role:

  • Bachelors degree in Biology, Chemistry or other life science related field of study
  • Minimum 8 years of pharmaceutical industry experience in clinical drug development.  
  • Minimum of 5 years working on IND and new drug product submissions

 

Preferred Qualifications:

  • PharmD, Masters or Ph.D.
  • Working knowledge of FDA, EMA, IM / regulations / guidance applicable to registration and approval of drugs or biologics
  • Experience (successful filing and defense of major submissions -- IND / NDA / BLA / CTA / MAA) setting and executing strategy in pre-clinical, clinical, or marketed products regulatory
     

Function

Regulatory Affairs

Sub Function

Medical Regulatory Affairs

Reports To

VP Global Regulatory Affairs

Already Working @TEVA?

If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

Teva’s 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. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience. Teva Pharmaceuticals USA requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, however, Teva will consider requests for reasonable accommodations.


Nearest Major Market: Philadelphia