Senior Associate, Global Regulatory Strategy for Oncology

Use Your Power for Purpose

At Pfizer, we are committed to bringing medicines to the world faster without compromising on excellence and integrity. Your dedication and expertise are vital in expanding and accelerating patient access to Pfizer medicines and vaccines. Adhering to both local and global regulations is crucial, and the constantly evolving regulatory landscape demands forward-thinking and meticulous attention to detail. Your role will be instrumental in ensuring that our life-saving treatments reach those in need, ultimately contributing to the betterment of global health.

ROLE SUMMARY:

• Accountable for ensuring US/regional contribution to Global Regulatory Strategies and implementation plans (including core labels, risk registers) for assigned projects.
• Ensures regulatory contributions achieve the objectives in the strategy, achieve agreed expectations, maximizing overall project delivery time and probability of success and facilitating post-filing activities
• Partners with key cross functional stakeholders in the Project Teams to ensure required regulatory contributions (line plans, label, NDA/sNDA, IND/CTA, MAA/IRD, variations, license renewals etc.) meet business needs and are provided to the project teams, to agreed time and quality standards.
• Develop and submit product registrations, progress reports, supplements, amendments, and periodic experience reports
• Ensures regulatory plans are monitored, progress/variance communicated to Global Regulatory Lead and Senior Management, and any risks (from emerging technical data, changing internal objectives or external threats) mitigated.
• Work with a certain degree of independence on moderately complex assignments and ensures an aligned regional regulatory position is reached for all key issues for assigned project/s, and that these regulatory positions supporting the regional business are championed and communicated.
• Engages in appropriate activities in order to influence the regional regulatory environment through OGRS-In Country colleagues, Agency contacts, and/or Trade Associations as appropriate.
• Ensures business compliance and implementation of and adherence to Regulatory standards.
• Develops and maintains, directly or indirectly, constructive working relationship with Health Authority contacts in the assigned region.

BASIC QUALIFICATIONS:

• Bachelors degree with at least 2 years of experience
• Effective delivery in a complex matrix environment
• Regulatory experience, including knowledge of New Drug Application (NDA) and Investigational New Drug (IND) submission processes
• Previous experience as a national and/or regional regulatory liaison for at least one product in different therapeutic areas and in different stages of the product life cycle is highly desirable. Equivalent experience, either at a regulatory agency or working on substantive industry -government collaborations, can be considered.
• Experience in communicating with FDA as well as participating in/leading such interactions, is preferred
• In-depth understanding of national and regional regulatory legislation and guidelines
• Proven ability in developing and implementing regulatory strategy - Understanding of regulatory agency philosophy and guidelines. Experience preparing and submitting INDs and/or CTAs, NDAs, amendments/supplements, is preferred.
• Communication skills - Ability to communicate complex information and analyses to a variety of scientific audiences in both verbal and written format, including to senior management.
• Presentation skills - Is effective in a variety of formal presentation settings; one- on-one, small and large groups, with peers, and in other cross-functional settings (eg Global Regulatory Sub Teams or Development Teams).

PREFERRED QUALIFICATIONS:

• Master's degree is highly desirable, coupled with relevant experience in the pharmaceutical industry
• Background in pharmaceuticals, providing a solid foundation for the role
• Experience in the pharmaceutical sector, enhancing the ability to contribute effectively
• Advanced education and practical experience, ensuring a well-rounded and capable professional

Relocation support may be available

Work Location Assignment: This is a hybrid role requiring you to live within commuting distance and work on-site an average of 2.5 days per week.

The annual base salary for this position ranges from $93,600.00 to $151,500.00. 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.

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Regulatory Affairs