Director, Regulatory Affairs

Teva Pharmaceuticals • West Chester, IA

58d

About The Position

We’re Teva, a leading innovative biopharmaceutical company, enabled by a world-class generics business. Whether it’s innovating in the fields of neuroscience and immunology or delivering high-quality medicine worldwide, we’re dedicated to addressing patients’ needs now and in the future. Here, you will be part of a high-performing, inclusive culture that values fresh thinking and collaboration. You'll have the room to grow, the flexibility to balance life with work, and the opportunity to better health worldwide, together.The opportunityThe Director, Global Regulatory Affairs, is a strategic role that will be 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 for conditions in Teva’s Immunology portfolio including dermatology, gastroenterology, respiratory, or other therapeutic areas. The position requires regulatory knowledge of and submission experience with investigational new drug applications (INDs) and new drug applications (NDAs)/biologic license applications (BLAs). Working within the Teva Innovative Medicines group, this role will contribute to the global and/or regional registration strategies to obtain marketing approval in focused countries as well as expanding into new indications with approved products.

Requirements

• Any equivalent combination of education, training, and/or experience that fulfills the requirements of the position will be considered.
• Education Required: Bachelor’s Degree in scientific field or equivalent combination of education and related work experience
• 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)
• Working knowledge of relevant drug and biologic regulations and guidances/guidelines applicable to registration and approval of drugs or biologics
• Excellent communication and organizational skills
• Company/Industry Related Knowledge: Experience with eCTD
• Domestic and international travel up to 10% pending project assignments (FDA or project team meetings)

Nice To Haves

• Education Preferred: PharmD, PhD, or Master’s degree

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.

Benefits

• Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.
• Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan.
• Time Off: Paid Time Off including vacation, sick/safe time, caretaker time and holidays.
• Life and Disability Protection: Company paid Life and Disability insurance.
• Additional benefits include, but are not limited to, Employee Assistance Program, Employee Stock Purchase Plan, Tuition Assistance, Flexible Spending Accounts, Health Savings Account, Life Style Spending Account, Volunteer Time Off, Paid Parental Leave, if eligible , Family Building Benefits, Virtual Physical Therapy, Accident, Critical Illness and Hospital Indemnity Insurances, Identity Theft Protection, Legal Plan, Voluntary Life Insurance and Long Term Disability and more.

What This Job Offers

• Job Type: Full-time
• Career Level: Director