Director, Regulatory Affairs (Early Development)

We Are Teva

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 opportunity

The 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.

How you’ll spend your day

• 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.

Your experience and qualifications

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

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

• 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)

How We’ll Take Care of You 

We offer a competitive benefits package, including:

• 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. 

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 policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, genetic information, marital status, sexual orientation, gender identity or expression, ancestry, national or ethnic origin, citizenship status, military status or status as a disabled or protected veteran, or any legally recognized status entitled to protection under applicable federal, state, or local laws.   

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. Request a reasonable accommodation by sending an email to [email protected] with the nature of your request and your contact information. Only inquiries concerning a request for a reasonable accommodation will be responded to from this email address.  

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.