Director, REMS Regulatory Strategy & Compliance

Cytokinetics; South San Francisco (CA); Hybrid; USD 263,880 - 307,860; Full time

Job summary

Cytokinetics is seeking a Senior Director for Regulatory Affairs in South San Francisco. This role involves leading regulatory strategies related to Risk Evaluation and Mitigation Strategies (REMS), ensuring compliance, and managing cross-functional teams.

The ideal candidate has over 10 years of experience in the pharmaceutical sector, with a strong background in REMS operations and strategy. The position offers a competitive salary range of $263,880 to $307,860 per year.

Qualifications

• 10+ years of relevant experience in the pharmaceutical/biotech industry.
• Strong expertise in REMS operations, strategy, and compliance.
• Understanding of GXP regulations.

Responsibilities

• Lead regulatory strategy and FDA interactions for REMS.
• Oversee REMS filings, assessments, and compliance activities.
• Manage cross-functional alignment in REMS discussions.

Skills

Regulatory strategy

REMS operations

Compliance oversight

Cross-functional team leadership

Excellent communication

Education

Bachelor’s degree in scientific discipline

Advanced degree (MD, PharmD, or PhD)

Job description

Cytokinetics is seeking a Senior Director for Regulatory Affairs in South San Francisco. This role involves leading regulatory strategies related to Risk Evaluation and Mitigation Strategies (REMS), ensuring compliance, and managing cross-functional teams.

The ideal candidate has over 10 years of experience in the pharmaceutical sector, with a strong background in REMS operations and strategy. The position offers a competitive salary range of $263,880 to $307,860 per year.