
VP Regulatory Affairs
Allucent
full-time
Posted on:
Location Type: Remote
Location: United States
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Job Level
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