Regulatory Affairs Senior Director - Global Regulatory Leader - Oncology
New
J
JobgetherBiotechnology, Oncology
Based in United StatesFull-TimeDirector
SalaryAnnual U.S. base salary range of $215,204.70–$291,159.30
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Job Details
- Experience
- Doctorate with 5+ years, Master's with 9+ years, or Bachelor's with 11+ years of relevant regulatory experience
- Required Skills
- LeadershipPeople Management
Requirements
- Doctorate degree with at least 5 years of regulatory experience, Master’s with 9+ years, or Bachelor’s with 11+ years.
- At least 5 years of direct people management and/or leadership experience.
- Demonstrated experience leading regulatory strategy for highly complex late-stage development programs.
- Contemporary oncology regulatory experience (strongly preferred).
- Proven experience leading submissions through approval of an original marketing application or major supplemental application.
- Strong understanding of global regulatory requirements and evolving agency expectations.
- Ability to develop and communicate comprehensive regulatory strategies to cross-functional teams.
- Strong scientific and clinical acumen for interpreting complex data.
- Exceptional written and verbal communication skills for presenting to senior leadership.
- Proven ability to influence cross-functional teams and senior stakeholders.
- Strong planning, prioritization, and decision-making skills.
Responsibilities
- Lead Global Regulatory Teams for high-complexity, late-stage oncology programs with multiple indications.
- Develop and execute comprehensive global regulatory strategies supporting product development, worldwide registration, and lifecycle management.
- Represent Global Regulatory Affairs on product teams and commercialization governance bodies to provide strategic direction.
- Lead the planning and execution of global regulatory submissions, including clinical trial applications and original marketing applications.
- Identify, communicate, and mitigate regulatory risks and uncertainties across development programs.
- Evaluate and incorporate regulatory mechanisms such as orphan designations, accelerated approvals, and pediatric plans.
- Lead formal and informal interactions with global regulatory agencies.
- Build, lead, and develop high-performing regulatory teams.
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