Director Regulatory Affairs Innovative Medicines (IM) Labeling

We Are Teva

Our Team, Your Impact

The Director of Regulatory Affairs, Innovative Medicines (IM) Labeling serves as a cross-functional subject matter expert for matters related to US drug product labeling, including all relevant FDA regulations and guidances as well as internal IM labeling processes and requirements. 

How You’ll Spend Your Day

• The Director develops and maintains the labeling for an individual portfolio of assigned product(s), including serving as the labeling contact with FDA and leading cross-functional labeling and Company Core Data Sheet (CCDS) development teams.


• Oversees development and maintenance of labeling SOPs and other process documents.


• Engages in strategic and cross-functional collaboration on various labeling development and governance committees.

Your Skills and Experience

• Bachelor’s degree required, preferably in a life sciences, pharmacy, or related field.


• Minimum of 6 years of relevant experience in the biopharmaceutical industry, with a substantial and dedicated focus on U.S. drug or biologic labeling across multiple lifecycle stages.


• Experience supporting both small molecule and biologic products preferred; combination product experience a plus.


• Expert-level knowledge of FDA labeling regulations and guidance documents, including requirements for format, content, and post-marketing change submissions.


• Thorough familiarity with: Structured Product Labeling (SPL) and drug listing; Company Core Data Sheet (CCDS) and Company Core Safety Information (CCSI) documents; Summary of Product Characteristics (SmPC); document management systems


• Strong analytical and writing skills; ability to distill complex scientific and regulatory information into clear, precise labeling language.


• Demonstrated ability to influence and to build credibility as a trusted advisor to labeling colleagues as well as across multiple functions and seniority levels in a collaborative, learning environment


• Basic understanding of drug development and worldwide regulatory labeling guidelines and their application to US labeling guidance in a global company


• Exceptional attention to detail, organizational skills, and the ability to manage multiple competing priorities in a fast-paced environment.

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.

The total compensation may also include restricted stock units and discretionary awards, depending on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.  

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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.   

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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.