Regulatory Affairs Associate
Posted on 2/13/2024
Cytokinetics

201-500 employees

Develops drugs for muscle-related debilitating diseases
Company Overview
Cytokinetics stands out as a leader in the biopharmaceutical industry with its specialized focus on muscle biology and the development of first-in-class muscle activators and next-in-class muscle inhibitors, addressing debilitating diseases where muscle performance is compromised. The company's commitment to positively impacting patients' lives is reflected in its culture, fostering resilience and fortitude among its employees. Recognized as a top workplace by the San Francisco Business Times, Fortune, and Great Place to Work-Certified, Cytokinetics offers a supportive and rewarding environment that encourages innovation and industry leadership.
Biotechnology

Company Stage

N/A

Total Funding

$1.2B

Founded

1998

Headquarters

South San Francisco, California

Growth & Insights
Headcount

6 month growth

0%

1 year growth

6%

2 year growth

61%
Locations
San Bruno, CA, USA
Experience Level
Entry
Junior
Mid
Senior
Expert
Desired Skills
Communications
CategoriesNew
Legal & Compliance
Requirements
  • Bachelor’s degree in biology, chemistry, or related discipline
  • 2+ years’ experience in regulatory affairs or drug development preferred
  • Ability to work effectively across teams, functions and with outside partners
  • Excellent oral and written communication skills
Responsibilities
  • Prepare and/or coordinate and comply routine regulatory submissions and other correspondence in accordance with regulatory agency regulations and guidelines
  • Review regulatory documents to ensure that all submissions are complete, accurate and meet relevant requirements
  • Interface with functional areas (CMC, Nonclinical, Clinical) to obtain information required for regulatory submissions
  • Assist with creating and maintaining regulatory timelines and tracking deliverables to ensure regulatory submission timelines are met
  • Assist with preparation for global regulatory team and subteam meetings
  • Develop and maintain tracking logs for regulatory activities
  • Monitor regulatory environment for changes to requirements
  • Support regulatory team through research on evolving regulatory issues, overall product landscape, etc, including searches of the relevant literature
  • Maintain current knowledge and expertise of FDA/EMA regulations and ICH guidelines
  • Collaborate with other functional areas in preparing and maintaining SOPs and appropriate regulatory operating guidelines
  • Assist with regulatory due diligence and inspection readiness activities
Desired Qualifications
  • RAC certification