Full-Time

Senior Manager

Regulatory Affairs

Posted on 5/14/2024

Cytokinetics

Cytokinetics

201-500 employees

Develops muscle function drugs for diseases

Biotechnology

Compensation Overview

$165k - $175kAnnually

Senior

San Bruno, CA, USA

Requirements
  • Bachelor’s degree in a scientific field
  • 8+ years of drug development experience
  • 5+ years of regulatory affairs experience in Biotech/Pharmaceutical industry
  • Experience in small molecule drug development
  • Experience in cardiovascular therapeutic area is a plus
  • Knowledge of international regulatory requirements
  • Experience with eCTD requirements and electronic submissions
  • Excellent communication and organizational skills
Responsibilities
  • Formulate regulatory strategies based on current regulatory intelligence
  • Collaborate with cross-functional teams to develop regulatory strategies
  • Manage preparation and submission of regulatory documents
  • Review global regulatory submissions for consistency
  • Prepare responses to queries from regulatory authorities
  • Maintain knowledge of FDA/EMA regulations and guidelines
  • Provide regulatory advice to other functional areas
  • Participate in regulatory due diligence activities
  • Build collaborative relationships with external partners and regulatory authorities
  • Supervise employees and manage regulatory operating guidelines

Cytokinetics is a late-stage biopharmaceutical company focused on developing small molecule muscle activators and inhibitors to address impaired muscle function in conditions such as heart failure, hypertrophic cardiomyopathy, and neuromuscular diseases. The company's main technologies involve engineering drug candidates to impact muscle function and contractility, with the goal of discovering, developing, and commercializing potential treatments for debilitating diseases.

Company Stage

IPO

Total Funding

$1.2B

Headquarters

South San Francisco, California

Founded

1998

Growth & Insights
Headcount

6 month growth

0%

1 year growth

4%

2 year growth

33%
INACTIVE