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 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.
• 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.
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)
We offer a competitive benefits package, including:
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 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.
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