Director, Regulatory Affairs

Role Summary

The Director, Global Regulatory Affairs is a strategic role responsible for developing, coordinating, and implementing regulatory strategies for drug 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 in Teva’s Immunology portfolio, including dermatology, gastroenterology, and respiratory areas. It requires regulatory knowledge of and submission experience with INDs and NDAs/BLAs. The role contributes to global and/or regional registration strategies to obtain marketing approval in focused countries as well as expanding into new indications with approved products.

Responsibilities

• Responsible for ensuring timely development of regulatory strategies through a global regulatory team approach for innovative 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.
• Leads the team in strategic regulatory planning, preparation, and execution of meetings with health authorities (e.g., FDA, EMA).
• Point-of-contact for interfacing with health authorities.
• Regularly reports and communicates to management on progress against objectives and plans, including program risk and mitigation strategies.
• 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 timely 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.

Qualifications

• Required: Bachelor’s Degree in scientific field or equivalent combination of education and related work experience.
• Preferred: PharmD, PhD, or Master’s degree.
• Required: Minimum of 8 years of pharmaceutical industry experience, including at least 5 years in regulatory affairs with proven experience (successful filing and defense of major submissions such as IND/NDA/BLA/CTA/MAA).
• Required: Working knowledge of relevant drug and biologic regulations and guidances/guidelines applicable to registration and approval of drugs or biologics.
• Required: Excellent communication and organizational skills.
• Company/Industry Related Knowledge: Experience with eCTD.

Education

• Education Required: Bachelor’s Degree in scientific field or equivalent combination of education and related work experience.
• Education Preferred: PharmD, PhD, or Master’s degree.

Additional Requirements

• Domestic and international travel up to 10% pending project assignments (FDA or project team meetings).