Assoc Regulatory Affairs Strategy Director (Oncology)
$195,000–$277,500 year
On-siteAlameda, California, United States
Job Summary
Develop and implement global regulatory strategies that align with asset and corporate goals while ensuring timely preparation of scientifically valid submissions. Conduct regulatory intelligence and research to guide study teams, providing risk assessments and recommendations for expedited pathways. Represent Regulatory Affairs in multi-disciplinary teams to establish development strategies for early and late-stage programs. Coordinate, author, and evaluate documents submitted to regulatory health authorities, including IND safety reports, annual reports, and new drug applications. Liaise with external vendors, licensors, and joint development collaborators to plan and maintain CTAs in Europe, Asia, and other regions. Lead multiple assets and studies as assigned, managing processes and procedures through the development of internal work instructions and SOPs.
Required Qualifications
- Bachelor's degree in related discipline
- Master's degree in related discipline
- PhD degree in related discipline
- Minimum of eleven years of related experience
- Minimum of nine years of related experience
- Minimum of five years of related experience
- Equivalent combination of education and experience
- Knowledge of the regulatory framework
- Knowledge of industry practices
- Clear and effective verbal and written communication
- Strong interpersonal skills
- Ability to accommodate differing views
- Ability to manage effectively performing teams
- Ability to engage internal stakeholders
- Skill in gathering, analyzing and applying key information to solve problems
- Ability to lead self and others
- Ability to act with integrity
- Ability to build trust with colleagues
- Capability of managing the execution of multiple tasks
- Ability to ensure appropriate prioritization and execution
- Ability to proactively anticipate, prioritize and resolve task-related challenges
- Ability to design and implement solutions to address task-related challenges
- Travel approximately 10%
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