Key skills
LeadershipMentoringCommunicationDecision MakingCritical ThinkingProblem Solving
About this role
Role Overview
- 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
- 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, and / or 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
- 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