Allucent

VP Regulatory Affairs

Allucent

full-time

Posted on:

Location Type: Remote

Location: United States

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About the role

  • At** Allucent™**, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.
  • - **Lead regulatory activities and team management**: Assist clients with regulatory aspects of drug, biologic, or medical device products; provide counsel, manage the regulatory team (potentially with direct reports), and translate requirements into practical plans while ensuring timely, scientifically valid submissions.
  • - **Oversee HA interactions and project leadership**: Lead/participate in Health Authority communications (e.g., meetings, teleconferences); review/author regulatory content for submissions; contribute expertise on drug/device development as a Leadership team member reporting to Senior Leadership, serving on project teams in roles like Subject Matter Expert or Project Lead.

Requirements

  • - B.Sc., M.Sc., Ph.D., or equivalent degree, in a scientific area, and equivalent combination of relevant experience in drug, biologic, or device development
  • - Advanced regulatory knowledge of drug, biologic, or device development focusing on regulatory requirements for US, EU/UK, and Canada
  • - RAC credentials preferred
  • Skills:
  • - Critical thinking and analytical skills, financial acumen, influencing and leading teams, risk assessment, problem solving skills, decision making, strong written and verbal communication skills in English
  • - Strong computer skills, including SharePoint, Word, Excel, and PowerPoint
  • - Quality focus
  • - Strong emotional intelligence, customer focused leadership and decision-making skills · Innovative, creative, and practical thinking including problem-solving skills.
Benefits
  • **Benefits of working at Allucent include:**
  • - Comprehensive benefits package per location
  • - Competitive salaries per location
  • - Departmental Study/Training Budget for furthering professional development
  • - Flexible Working hours (within reason)
  • - Opportunity for remote/hybrid* working depending on location
  • - Leadership and mentoring opportunities
  • - Participation in our Buddy Program as a new or existing employee
  • - Internal growth opportunities and career progression
  • - Financially rewarding internal employee referral program