REMS Regulatory Strategy Director

Cytokinetics, Inc.; United States; On-site; USD 263,880 - 307,860; Full time

Job summary

Cytokinetics, Inc. is seeking a Regulatory Lead to manage REMS-related interactions with the FDA. The successful candidate will possess over 10 years of experience in the pharmaceutical or biotech industry, specifically in REMS operations and strategy. Responsibilities include leading REMS strategies, overseeing regulatory compliance, and preparing submissions.

A Bachelor’s degree in a scientific discipline is required, with advanced degrees preferred. The role offers a salary range of $263,880 - $307,860 per year.

Qualifications

• 10+ years of relevant experience in the pharmaceutical/biotech industry.
• Strong expertise in REMS operations, strategy, and compliance.
• Excellent knowledge of regulatory requirements applicable to REMS.

Responsibilities

• Serve as regulatory lead for all REMS-related interactions.
• Lead development of REMS strategies.
• Prepare and lead REMS discussions for FDA meetings.
• Manage REMS filings, assessments, and queries.

Skills

REMS operations

Regulatory compliance

Cross-functional collaboration

Leadership and mentoring

Communication skills

Education

Bachelor’s degree in a scientific discipline

Advanced degree (MD, PharmD, or PhD)

Job description

Cytokinetics, Inc. is seeking a Regulatory Lead to manage REMS-related interactions with the FDA. The successful candidate will possess over 10 years of experience in the pharmaceutical or biotech industry, specifically in REMS operations and strategy. Responsibilities include leading REMS strategies, overseeing regulatory compliance, and preparing submissions.

A Bachelor’s degree in a scientific discipline is required, with advanced degrees preferred. The role offers a salary range of $263,880 - $307,860 per year.