Allucent

Helping bring new therapies to light

VP Regulatory Affairs

ComplianceComplianceFull TimeRemoteTeam 1,001-5,000H1B No SponsorCompany SiteLinkedIn

Location

United States

Posted

2 days ago

Salary

Not specified

Postgraduate DegreeEnglish

Job Description

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.

Job 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

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