Head of Regulatory Affairs Strategy

1 week ago


San Diego, California, United States Cypress HCM Full time

Exciting Opportunity in Regulatory Affairs

Are you an experienced professional with a strong background in global regulatory management and project execution? As a pivotal member of Cypress HCM, you will be instrumental in advancing our objectives within the pharmaceutical sector. In the role of Regulatory Affairs Director, you will be responsible for steering the development of innovative products while ensuring adherence to international regulations.

Key Responsibilities:

  • Act as the primary representative for the Regulatory Affairs division within product development teams
  • Formulate comprehensive global regulatory strategies for product advancement
  • Lead the creation of international product development frameworks
  • Investigate regulatory trends and potential opportunities
  • Manage the global regulatory lifecycle of investigational products
  • Engage with regulatory health authorities
  • Assist in the formulation of standard operating procedures
  • Track the organization’s progress in fulfilling regulatory obligations

Qualifications:

  • Bachelor's degree in life sciences; advanced degree is advantageous
  • Regulatory Affairs Certification is a plus
  • Extensive experience in pharmaceutical Regulatory Affairs
  • Familiarity with US and international regulatory bodies
  • Thorough understanding of global regulatory frameworks
  • Exceptional communication, analytical, and project management capabilities
  • Proven ability to thrive in a fast-paced environment

Compensation:

· $165-225K



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