Executive Director, Regulatory Science & Strategy – Oncology
AstraZeneca
full-time
Posted on:
Location Type: Hybrid
Location: Gaithersburg • Maryland, Massachusetts • 🇺🇸 United States
Visit company websiteJob Level
Lead
About the role
- Coach and mentor regional (US and EU regulatory leads) and global regulatory leads, including identification of skill development opportunities regulatory professionals with different levels of experience
- Partner with Regulatory Affairs Directors aligning on global innovative regulatory strategies for products
- Lead resource planning and recruitment of staff
- Provide critical review and input on disease area and portfolio regulatory strategies, risk planning and mitigations
- Effectively represent the Global Regulatory Affairs function in senior level interactions at internally governance technical review committees, key global health authority meetings and external partners
- Collaborate with regional policy and intelligence groups to critically analyze the assessment of emerging science, data and changes in the regulatory environment and advise senior management on project risks/mitigation activities accordingly
- Define and drive disease area global regulatory policies and priorities
- Review and approve high-level documents for global regulatory submissions as well as core prescribing information
- Ensure submission excellence framework is timely and consistently applied across projects including sharing the best submission practices and knowledge and using existing tools
- Sponsor key non-drug project workstreams, business initiatives, external activities and meetings and act as a subject matter expert
Requirements
- Bachelor’s degree in life sciences and/or science related field and/or other appropriate knowledge/experience
- More than 10 years drug development experience
- Oncology therapy area knowledge/experience, ideally expertise with Hematology assets
- Deep knowledge of global regulatory strategy experience with all phases of oncology drug development, including early drug development as well as direct involvement in marketing applications that have progressed through to registration
- Significant experience in leading major health Authority interactions
- Proven experience of growing high performance teams, attracting top talent, and developing capabilities of regional and global regulatory leads
- Experience in leading people in a matrixed interpersonal 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
- Advanced degree in a scientific subject area (e.g. MSc, PhD, PharmD, MD) - preferred
Benefits
- Health insurance
- Professional development opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory strategydrug developmentoncologyHematologyregulatory submissionsrisk planningsubmission excellence frameworkproject managementdata analysisglobal health authority interactions
Soft skills
coachingmentoringstrategic thinkingcritical evaluationteam leadershipinterpersonal skillscollaborationcommunicationtalent attractioncapability development
Certifications
Bachelor’s degreeMScPhDPharmDMD