VP Regulatory Affairs
About The Position
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. We are looking for a Vice President of Regulatory Affairs to join our A-team (hybrid/remote). As a VP Regulatory Affairs at Allucent, you are responsible for assisting clients with the regulatory activities of drug, biologic or medical device product. About the role As the VP Regulatory Affairs, you will: 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. This role is open to considering candidates from United States, Canada, Countries within the EU, and United Kingdom.
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, and / or Canada
- 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
Nice To Haves
- RAC credentials preferred
Responsibilities
- Assist clients with regulatory aspects of drug, biologic, or medical device products
- Provide counsel
- Manage the regulatory team (potentially with direct reports)
- Translate requirements into practical plans while ensuring timely, scientifically valid submissions
- 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
Benefits
- 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
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Executive
Education Level
Ph.D. or professional degree
