Director, Regulatory Affairs jobs in United States
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Teva Pharmaceuticals · 1 day ago

Director, Regulatory Affairs

Teva Pharmaceuticals is a leading manufacturer of generic medicines, aiming to make good health more affordable and accessible. The Director of Global Regulatory Affairs will develop and implement regulatory strategies for drug development programs and manage regulatory submissions for innovative biologic and small molecule products.

BiopharmaHealth CareMedicalPharmaceutical
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H1B Sponsor Likelynote

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

Qualification

Regulatory AffairsIND/NDA/BLA submissionPharmaceutical industry experienceECTD experienceDrug regulations knowledgeCommunicationOrganizational skillsLeadershipMentorship

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
Experience with eCTD

Preferred

PharmD, PhD, or Master's degree

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.
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
Long Term Disability and more.

Company

Teva Pharmaceuticals

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Teva Pharmaceuticals is a pharmaceutical company that develops generic and innovative medicines.

H1B Sponsorship

Teva Pharmaceuticals has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (7)
2024 (4)
2023 (23)
2022 (48)
2021 (31)
2020 (33)

Funding

Current Stage
Public Company
Total Funding
$5.51B
Key Investors
Royalty PharmaBerkshire Hathaway
2026-01-11Post Ipo Equity· $500M
2025-05-20Post Ipo Debt· $2.3B
2023-11-13Post Ipo Equity· $100M

Leadership Team

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Dipankar Bhattacharjee
President & CEO: Generics Europe
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Richard Francis
President and Chief Executive Officer
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Company data provided by crunchbase