REMS Operations Director: Regulatory Strategy

Teva Pharmaceuticals; Parsippany-Troy Hills (NJ); Hybrid; USD 170,000 - 213,000; Full time

Benefits offered by this job

Comprehensive Health Insurance

401(k) Retirement Savings

Paid vacation and holidays

Life and Disability Protection

Tuition Assistance

Job summary

Teva Pharmaceuticals is seeking a Director, REMS Operations in Parsippany, NJ. This role involves developing and implementing Risk Management Programs, ensuring compliance with FDA regulations, and managing a team of 3.

The ideal candidate will have significant experience in pharmaceutical safety, vendor management, and project leadership. A Bachelor’s degree is required, while a Master's degree in a healthcare discipline is preferred. The position offers a hybrid work model and a competitive salary.

Qualifications

• Minimum of 10 years managing large projects/programs in a regulated industry.
• 5 years working with FDA on regulatory submissions.
• Pharmaceutical drug safety and regulatory experience preferred.

Responsibilities

• Develop and manage Risk Management Programs for a small portfolio of products.
• Evaluate and select vendors, develop and manage vendor contracts.
• Accountable for the departmental budget and financials.

Skills

FDA regulatory knowledge

Analysis / Problem Solving

Interpersonal skills

Leadership and Teamwork

Communication

Technical Skills

Education

Bachelor’s degree or equivalent

Master’s Degree in a healthcare discipline or MBA

Tools

Software systems

Call-center technologies

Job description

Teva Pharmaceuticals is seeking a Director, REMS Operations in Parsippany, NJ. This role involves developing and implementing Risk Management Programs, ensuring compliance with FDA regulations, and managing a team of 3.

The ideal candidate will have significant experience in pharmaceutical safety, vendor management, and project leadership. A Bachelor’s degree is required, while a Master's degree in a healthcare discipline is preferred. The position offers a hybrid work model and a competitive salary.