Executive Director – Global Regulatory Science & Strategy – Oncology
| Company | AstraZeneca |
|---|---|
| Location | Boston, MA, USA, Cambridge, UK, Gaithersburg, MD, USA, Sant Cugat del Vallès, Barcelona, Spain |
| Salary | $266093 – $399140 |
| Type | Full-Time |
| Degrees | Bachelor’s |
| Experience Level | Expert or higher |
Requirements
- Bachelor’s degree in life sciences or related field
- A minimum of 10 years of proven experience in strategic drug development
- Deep oncology therapy area knowledge, including understanding of scientific, medical and regulatory environments
- Varied experience in global regulatory strategy across the phases of drug development, including both early and late drug development
- Direct experience in filing global marketing applications and achieving product licensure
- Significant experience in leading major health authority interactions in major markets
- Broad background of experience working in pharmaceutical/medical industry and prior experience in several areas within regulatory affairs, e.g. Global, European, International, Marketing Company or experience at a health authority
- Experience in managing people both directly and in a matrixed organizational structure
- Ability to think strategically and critically to evaluate risks to regulatory product development and approval, market entry and license maintenance activities
- Ability to travel domestically and internationally
- Excellent communication and influencing skills
Responsibilities
- Provide critical review and input on multiple oncology disease area and portfolio regulatory strategies, risk planning and mitigations
- Define and drive disease area global regulatory priorities
- Review and/or approve critical documents with regulatory intent, including briefing documents for health authority interactions
- Ensure timely and high-quality marketing applications using existing tools as well as sharing the best submission practices and knowledge
- Effectively represent the Global Regulatory Affairs function in senior level interactions at internal governance technical review committees, key global health authority meetings and with external partners
- Lead, develop and coach Regulatory Affairs Directors (US and EU regional regulatory leads) and Senior Directors (global regulatory leads), as well as recruit new staff
- Collaborate with regional policy and intelligence groups to critically analyze emerging science, data and changes in the regulatory environment and advise senior management on project risks and mitigations activities accordingly
Preferred Qualifications
- Advanced degree in a scientific subject area
- Experience working within an alliance