VP Regulatory Affairs

VP Regulatory Affairs at Allucent VP Regulatory Affairs at Allucent in Cary, North Carolina Posted in 15 days ago.

Job Description:

Allucent Location:

United States Department:

Regulatory Affairs 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. 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. 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 Point, 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

Disclaimers:

•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. "The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively "Allucent"). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources." #LI-Remote #LI-Hybrid #LI-TCW Equal employment opportunity, including veterans and individuals with disabilities. PI283094318