- Develop and implement US regulatory strategy to successfully register and manage unique and technologically complex products for patients with rare diseases.
- Develop and direct innovative regulatory strategies for specific projects and Alexion's portfolio.
- Act as strategic lead for US programs and submission sub-team lead.
- Provide regulatory guidance for marketed and pipeline products, collaborating with various departments within Alexion.
- Prepare and execute regional aspects of global regulatory strategy.
- Lead US submissions to regulatory authorities for development programs.
- Monitor new regulatory requirements and advise product teams.
- Support due diligence initiatives for regulatory affairs.
- Maintain exemplary behavior and transparency within the company and with regulatory agencies.
- Strong knowledge of US drug development and regulatory policy.
- Experience in providing US strategic regulatory advice for product development.
- Experience with major submissions and FDA meetings.
- Ability to manage complex issues and projects simultaneously.
- Strong interpersonal and communication skills.
- Proven track record of sound judgment and risk assessment.
- Familiarity with new regulations and guidances.
- Bachelor's Degree in a related discipline.
- Experience in Advisory Committee.
- Experience in cell and gene therapy.
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Director, Global Regulatory Affairs, Development Strategy - Boston, United States - AstraZeneca
Description
Director, Global Regulatory Affairs, Development StrategyWhat you will do:
Responsibilities:
Requirements:
Preferred qualifications:
Alexion is an Equal Employment Opportunity and Affirmative Action employer, committed to fostering a culture of belonging and diversity.
Alexion provides reasonable accommodations to candidates and employees. The Company participates in E-Verify.
AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by law.
