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Director, Regulatory Affairs, Strategy - Innovative Medicine (West Chester, PA or Remote)

Date: Feb 2, 2024

Location: 

West Chester, United States, Pennsylvania, 19380

Company: Teva Pharmaceuticals

Job Id: 53865

Who we are

Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.

The opportunity

The Director, Global Regulatory Affairs, is a strategic role that will be responsible for developing, coordinating, and implementing regulatory strategies for early and/or late stage development programs for innovative biologic and small molecule products, as well as marketed products.

This position will support the development and lifecycle management of therapies for conditions in Teva’s immuno-oncology and neuroscience portfolio, and other therapeutic areas as assigned. The position requires regulatory knowledge of IND and NDA/BLA content and submission experience. 

Working within Teva Innovative Medicines, this role will contribute to the global and/or regional registration strategies to obtain marketing approval in focus countries as well as expanding into new indications with approved products. This role may include managing direct reports.

Travel Requirements: 10% (domestic and/or international travel for FDA or project team meetings)

Location: On-Site in West Chester, PA or Remote (anywhere in the US)

RELOCATION ASSISTANCE AND WORK VISA SPONSORSHIP IS AVAILABLE

How you’ll spend your day

  • Responsible for ensuring timely development of regulatory strategies through a global regulatory team approach for branded products.
  • As a global or regional lead within a global regulatory team, develops/coordinates/implements regulatory strategy as a valued member of a multi-disciplinary project team for branded products
  • Leads the team in planning, preparation, and execution of meetings with health authorities (e.g., FDA, EMA). Point-lead for interfacing with health authorities.
  • Regularly reports to management on progress against objectives and plans.
  • Plans and directs projects and provides technical background, inspiration, leadership, regulatory intelligence, and consultation to cross-functional colleagues as well as members of the global regulatory team.
  • Lead facilitator for the submission and approval of regulatory applications and coordinates appropriate responses to health authorities to resolve outstanding regulatory issues.
  • Provides training and mentorship to regulatory staff.

Your experience and qualifications

Required:

  • Bachelor’s Degree in scientific field or equivalent combination of education and related work experience 
  • Minimum of 8 years of relevant pharmaceutical industry experience, including at least 5 years in a strategic position in regulatory affairs with proven experience (filing and defense of major submissions such as IND/NDA/BLA/CTA/MAA).

Preferred:

  • PhD or Masters in relevant discipline, or professional degree (eg, DVM, DDS, MD, PharmD)
  • Prior oncology experience preferred.
  • Experience in Oncology, Immuno-oncology, and Neuroscience
  • Working knowledge of relevant drug and biologic regulations and guidances / guidelines applicable to registration and approval of drugs or biologics
  • Working knowledge of relevant drug, biologic and combination product laws regulations/guidances and how they inform regulatory strategy for innovative medicine development; working in a matrixed cross functional project team and global regulatory team

Enjoy a more rewarding choice

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, 13 paid Holidays, 6% match on the 401(k), Employee Stock Purchase Plan, and Tuition Assistance

Reports To

Senior Director, 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.

Important notice to Employment Agencies - Please Read Carefully

Teva Pharmaceuticals USA does not accept unsolicited assistance from agencies for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

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Confirmed 16 hours ago. Posted 30+ days ago.

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