Manager, Regional Regulatory Strategist

ROLE SUMMARY The role supports a senior regulatory professional by executing against the global regulatory plan for one or more products. This positionrepresentsRegulatory on cross-functional teams and manages the development and preparation of regulatory documentation to regulatory authorities. ROLE RESPONSIBILITIES:

• Provide regulatory representation at cross-functional team meetings, including tactical support and clarity on regulatory expectations and timelines
• Prepare, maintain and/or coordinate global regulatory submissions (INDs, CTAs, marketing applications) in accordance with applicable regulations
• Understand and can challenge scientific arguments, identifies regulatory scientific data needs and solves regulatory issues.
• Serve as primary contact to FDA (or other relevant regulatory authorities) for routine communications in support of submissions
• Assist in preparation for and participate in regulatory authority meetings including preparation of briefing packages and strategy for meetings, inspections, advisory committee meetings, and response to agency letters pertaining to the assigned products/teams
• Work with contract research organizations for ex-US regulatory submissions

BASIC QUALIFICATIONS

• Bachelor's degree in scientific discipline and a minimum of 5 years regulatory experience; or Master's degree with minimum 3+ years experience
• Oncology experience preferred
• Solid knowledge and understanding of the drug development process and regional regulatory requirements
• Experience in the preparation/submission of regulatory documentation to support regulatory submissions
• Excellent oral and written communication skills
• Strong technical/analytical skills to identify and solve problems independently
• Proven ability to manage multiple projects, identify and resolve regulatory issues
• Willingness to work collaboratively
• 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

PREFERRED QUALIFICATIONS

• Advanced degree preferable e.g. PharmD
• Relevant pharmaceutical experience
• Demonstrated experience in regulatory affairs or compliance
• Experience working cross-functionally on broad and strategic initiatives

The annual base salary for this position ranges from $88,300.00 to $147,100.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 12.5% 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 | (uscandidates.mypfizerbenefits.com). 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