Job Details: Director, Regulatory Affairs – Commercial Regulatory (Europe) & GM (Ireland)
Vacancy Name: Director, Regulatory Affairs – Commercial Regulatory (Europe) & GM (Ireland)
Vacancy No: VN440
Employment Type: Permanent
Location of role: Republic of Ireland
About 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 Proficiency
2. Leadership
3. Critical Thinking
4. Problem Solving
5. Strong knowledge of EU regulations
6. Time Management
7. Collaboration Skills
8. Personal Effectiveness/Credibility
9. Flexibility
10. Stress Management/Composure
Immunocore 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
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