Associate Director, Regulatory Affairs

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 Associate Director, Global Regulatory Affairs, will be responsible for providing regulatory guidance to product development teams and regulatory submission support within Teva’s Immunology portfolio, including respiratory, dermatology, gastroenterology, or other therapeutic areas within the Global Regulatory Affairs Innovative Medicines organization. The individual will assist in the preparation of regulatory submissions for the US or other regions, and interact with regulatory authorities as needed.

 

Under the guidance of the Director, the successful candidate will provide the regulatory strategy and submission support for early and/or late stage development programs as well as marketed products for biologics and/or small molecules.

 

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.

How you’ll spend your day

• 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 innovative products.

• With guidance from the Director, plans and directs projects and provides technical background and consultation to cross-functional colleagues as well as members of the global regulatory team.

• Critically reviews clinical and non-clinical aspects of submissions for accuracy of content, completeness, and compliance with applicable regulations or guidance. Perform gap analyses and work with functional areas to address deficiencies.

• Manage day-to-day project activities related to assigned products. Support maintenance activities for investigational new drug applications (INDs), new drug applications (NDAs) and/or biologic license applications (BLAs).

• Correspond with and respond to inquiries from regulatory agencies.

• Assist in implementation of electronic document management system in the department.

• Plan and oversee the compilation of FDA submissions, including initial INDs, original and supplemental NDAs/BLAs, annual reports, responses to Requests for Information, etc.

• Maintains thorough knowledge of the laws, regulations and guidelines covering pre and post approval regulatory requirements and application maintenance.

Your experience and qualifications

Any equivalent combination of education, training, and/or experience that fulfills the requirements of the position will be considered.

• Bachelor degree in scientific field or equivalent combination of education and related work experience.

• At least 5 years of regulatory affairs or relevant pharmaceutical industry experience.

• Must be familiar with IND and/or NDA/BLA submission requirements.

• Working knowledge of FDA regulations / guidance applicable to registration and approval of drugs or biologics.

• Excellent communication and organizational skills.

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

Enjoy a more rewarding choice

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, Volunt