Regulatory Affairs Manager Job at GForce Life Sciences, Santa Clara, CA

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  • GForce Life Sciences
  • Santa Clara, CA

Job Description

Job Summary:

We seek a Regulatory Affairs Manager to oversee regulatory activities, ensure compliance, and provide strategic guidance. The ideal candidate has strong operational skills, exceptional communication, and experience collaborating in a matrixed environment.

Responsibilities:

  • Develop and execute regulatory strategies.
  • Interpret and apply relevant regulations.
  • Provide guidance to cross-functional teams.
  • Prepare and submit regulatory documents.
  • Monitor and analyze regulatory changes.
  • Build relationships with regulatory agencies.
  • Represent regulatory affairs in project meetings.
  • Develop innovative solutions to regulatory challenges.

Qualifications:

  • PhD/PharmD with 2+ years in regulatory affairs or MS with 4+ years or BS with 5+ years of experience.
  • Strong knowledge of applicable regulations.
  • Excellent project management and communication skills.
  • Ability to work independently and collaboratively.
  • Proactive problem-solving and relationship-building skills.

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