Job Description
Job Details: Director, Regulatory Affairs – Commercial Regulatory (Europe) & GM (Ireland)Vacancy Name: Director, Regulatory Affairs – Commercial Regulatory (Europe) & GM (Ireland)Vacancy No: VN440Employment Type: PermanentLocation of role: Republic of IrelandAbout the Company: Immunocore (NASDAQ: IMCR) is a pioneering, commercial-stage T cell receptor biotechnology company whose purpose is to develop and commercialize a new generation of transformative medicines which address unmet patient needs in oncology, infectious diseases and autoimmune disease. We strive to create a diverse and inclusive workplace, while seeking talented individuals to work with us across many functions to deliver new medicines that transform the lives of patients.Key Responsibilities:• Integrate the European regulatory, legal, scientific/medical and business perspectives to accomplish optimal regulatory results consistent with company goals.• Translate tactics into operational objectives and targets for Europe.• Ensure high-quality implementation of plans.• Provide input from EU perspective for maximizing development plans for commercial projects in Europe.• Converse with global regulatory affairs colleagues consistently and in a timely manner.• Anticipate and act on trends in the European regulatory setting.• Author documents for EU specific regulatory purposes.• Implement deliberations with EMA and local country Health Authorities.• Coordinate regulatory documentation with vendors for submissions where required.• Develop processes for timely implementation of changes to labelling in EU.• Be the center of excellence for all regulatory requirements in Europe.• Involvement in Board meetings and corporate matters for Immunocore Ireland.• General Management of Irish office and act as Immunocore group’s named contact in Ireland/EU.• Other duties may be assigned.Supervisory Responsibility: This position does not initially have direct reports, but may in the future.Experience & Knowledge:Essential:• Familiar with oncology, and experience preferred.• Analytical capabilities.• Excellent communication skills.• Strong understanding of European regulatory requirements.• Experience in managing, preparing, submitting documents for regulatory approvals.Preferred:• Experience in oncology, anti-infectives, or autoimmune disease regulatory requirements.Education & Qualifications:5-10 years’ experience in regulatory affairs in a biopharmaceutical organization. Undergraduate degree in scientific discipline, with advanced degree desirable.Competencies:1. Communication Proficiency2. Leadership3. Critical Thinking4. Problem Solving5. Strong knowledge of EU regulations6. Time Management7. Collaboration Skills8. Personal Effectiveness/Credibility9. Flexibility10. Stress Management/ComposureImmunocore Values:• We lead with science to benefit patients• We are entrepreneurial• We value diversity to drive innovation• We respect each other and act with integrity• We do the right thing #J-18808-Ljbffr