Director Regulatory Innovative Medicine - Dossier Project Manager - West Chester, PA

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 Regulatory Innovative Medicine Dossier Project Manager, a key member of Global Regulatory Affairs, will be responsible to develop and manage detailed regulatory project plans for major global dossiers. The Director that fills this highly visible role will work in a matrixed cross functional project team, interacting with contributors and leadership within the R&D environment to align optimal submission plans with demanding timelines in full compliance with external and internal requirements.

This role will lead multidisciplinary Product Submission Teams where they will manage regulatory document planning, establish dossier timelines, identify and expedite critical path deliverables, and orchestrate hand-offs to Regulatory Operations or the local International Market RA teams. The individual will also conduct scenario and contingency planning to avoid time delays. The ideal candidate will develop efficient and innovative approaches to successfully deliver on-time and high-quality dossiers.

This role requires utilization of in-depth knowledge of global regulatory submission requirements, processes and procedures, eCTD structure/format, and the ability to rapidly learn associated Teva systems and planning software. The position requires regulatory knowledge of content requirements of and experience with major applications, including global NCE marketing applications, product line extensions and supplements.

This is primarily an individual contributor role, though it may include managing 1 or more direct reports at a later stage.

How you'll spend your day

• Responsible to manage Product Submission Team and dossier timelines.

• Accountable to Global Regulatory Lead and Global Regulatory Affairs, with matrixed accountability to Project Management.

• Regularly reports to management on progress against objectives and plans.

• Guides project teams on Teva submission-related processes and content and format requirements for key markets.

• In close collaboration with cross functional team members, creates and maintains regulatory project plans that capture detailed dossier content, key activities and timelines required to deliver that content to achieve aggressive submission timelines for highly prioritized major applications.

• Leads submission planning discussions, keeping all stakeholders informed and engaged of upcoming deliverables, aligned on roles and responsibilities, and aware of the interdependencies between R&D activities and submission components. Identify, communicate, and mitigate any issues, risks, or adaptations needed as challenges arise.

• In collaboration with regulatory lead and project leader, conduct scenario planning when multiple regulatory strategies are being considered.

• Communicate key milestones, critical path activities, and ensure transparency of regulatory plan status to stakeholders.

• Understands and advises others on global Regulatory Authority regulations and guidance associated with required submission components, which differ across regions and Regulatory Authorities.

• Provides training and mentorship to regulatory staff.

Your experience and qualifications

• Education Required: Bachelor's Degree in scientific field or related area

• Education Preferred: Ph.D or Masters in relevant discipline, or professional degree (eg, Project Management Professional (PMP), DVM, DDS, MD, PharmD).

• Minimum of 8 years of relevant pharmaceutical industry experience required

• Minimum of 5 years in a related position in regulatory affairs project management (creating, filing and defense of major submissions such as IND/NDA/BLA/CTA/MAA).

• Working knowledge of relevant drug and biologic regulations and guidances / guidelines applicable to marketing applications drugs or biologics preferred

• Excellent communication, organizational, and interpersonal skills

• Must be adept at working and positively influencing upward and laterally in a matrixed cross functional project team and global regulatory team environment

• Proficiency in electronic Document Management Systems (eDMS), Veeva preferred

• Strong understanding of Microsoft Office Suite (Word, Excel, PowerPoint, MS Project)

• Availability for domestic and international travel up to 10% pending project assignments (such as project team meetings)

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.

Already Working @TEVA?

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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. 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.

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