Senior Director, REMS Strategy & Compliance

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

Job summary

Cytokinetics in San Francisco seeks a Senior Director of Regulatory Affairs. You will be responsible for leading REMS strategy and execution, ensuring compliance with FDA regulations.

Successful candidates will have over 10 years of experience in the pharmaceutical or biotech industry, a Bachelor’s degree in a scientific field, and excellent skills in communication and regulatory oversight. The position offers a competitive salary range of $263,880 - $307,860 annually.

Qualifications

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

Responsibilities

• Lead regulatory strategy for REMS and oversee compliance.
• Manage preparation and submission of REMS filings.
• Provide regulatory guidance to teams for compliant execution.

Skills

REMS operations

Regulatory compliance

Oral and written communication

Organizational skills

Cross-functional teamwork

Education

Bachelor's degree in a scientific discipline

Advanced degree (MD, PharmD, or PhD)

Job description

Cytokinetics in San Francisco seeks a Senior Director of Regulatory Affairs. You will be responsible for leading REMS strategy and execution, ensuring compliance with FDA regulations.

Successful candidates will have over 10 years of experience in the pharmaceutical or biotech industry, a Bachelor’s degree in a scientific field, and excellent skills in communication and regulatory oversight. The position offers a competitive salary range of $263,880 - $307,860 annually.