Senior Manager, Global Regulatory Strategy for Oncology
Why Patients Need You
We're looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and the ever-changing regulatory environment requires forward thinking and attention to detail. Your dedication and expertise will help expand and accelerate patient access to Pfizer medicines and vaccines.
What You Will Achieve
The Senior Manager, Global Regulatory Strategy for Oncology provides support to Director and above regulatory professionals by executing against the global regulatory plan for one or more products. This position represents Regulatory on cross-functional teams and leads the development and preparation of regulatory documentation to regulatory authorities.
As a Senior Manager, your advanced knowledge of the principles and concepts in the discipline and comprehensive knowledge of other disciplines will enable you to lead complex projects across the division. Your ability to develop and manage plans will facilitate in achieving objectives, interpreting internal and external business challenges and recommending best practices for improvements. While managing complex project environments, you will be able to anticipate and troubleshoot roadblocks and influence teams to achieve targets for the division.
How You Will Achieve It
- Develop integrated regulatory plans that deliver against strategic objectives, maintain compliance, and protect patients.
- Ensure receipt of timely and actionable regulatory authority feedback around key issues and program milestones, by defining the strategy and content to support agency interactions.
- Function as primary liaison with regulatory authorities, including providing complete and timely responses to regulatory authority requests for information.
- Assess regulatory program risks for likelihood and impact; establish mitigation strategies.
- Oversee the planning and preparation of submissions to regulatory authorities, related to IND/CTA maintenance.
- Advise on regulatory requirements, expected outcomes, and changes to landscape.
Qualifications
Must-Have
- Bachelor's Degree (BA/BS) and 10+ years of experience.
- Strong knowledge and understanding of the drug development process and regional regulatory requirements.
- Experience interacting with regulatory authorities.
- Excellent oral and written communication skills for effectively interfacing with all levels of management and departments within the company.
- Strong technical/analytical skills to identify and solve problems independently.
- Proven ability to manage multiple projects, identify and resolve regulatory issues.
- Ability to interpret and understand regulations in the context of the scientific and commercial environment and balance regulatory objectives with business objectives.
- Willingness to work collaboratively and incorporate diverse perspectives into decision-making.
- Self-motivated, assertive, and self-confident.
- Strong organizational skills in order to maintain a high level of productivity, innovation, and priority-setting.
- Ability to work under pressure, meeting time sensitive deadlines, while maintaining a high level of quality.
- Proactively seeks out and recommends process improvements.
- Enjoys working in a fast-paced environment.
Nice-to-Have
- Master's degree (MA/MBA/MS) and 7+ years of experience.
- Doctorate (PhD/PharmD/JD) with 4+ years of experience.
- Oncology experience preferred.
- Lean and/or Six Sigma experience.
- Experience using continuous improvement techniques.
- Demonstrated ability to work with or lead a team in a matrix structure.
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