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about 1 month ago
Requirements and responsibilities
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 and Canada.RequirementsB.Sc., M.Sc., Ph.D., or equivalent degree, in a scientific area, and equivalent combination of relevant experience in drug, biologic, or device developmentAdvanced regulatory knowledge of drug, biologic, or device development focusing on regulatory requirements for US, EU/UK, and CanadaRAC credentials preferredSkills: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 EnglishStrong computer skills, including SharePoint, Word, Excel, and PowerPointQuality focusStrong emotional intelligence, customer focused leadership and decision-making skills · Innovative, creative, and practical thinking including problem-solving skills.BenefitsBenefits of working at Allucent include:Comprehensive benefits package per locationCompetitive salaries per locationDepartmental Study/Training Budget for furthering professional developmentFlexible Working hours (within reason)Opportunity for remote/hybrid* working depending on locationLeadership and mentoring opportunitiesParticipation in our Buddy Program as a new or existing employeeInternal growth opportunities and career progressionFinancially rewarding internal employee referral programDisclaimers:*Our office-based work policy encourages a dynamic work environment, prescribing a minimum of 2 days in office per week for employees within reasonable distance from one of our global offices.
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