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.

It is your hard work and leadership that will make Pfizer ready to achieve new milestones and help patients across the globe.

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.

The annual base salary for this position ranges from $131,200.00 to $218,600.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 17.5% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | (~~~). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.

Relocation assistance may be available based on business needs and/or eligibility.

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States.

Regulatory Affairs