Pfizer · 17 hours ago
Senior Associate, Global Regulatory Strategy for Oncology
United States - New York - New York City
Full-time
Hybrid
Mid, Senior Level
$94K/yr - $152K/yr
2+ years expPfizer is committed to bringing medicines to the world faster without compromising on excellence and integrity. The Senior Associate will be accountable for ensuring US/regional contributions to Global Regulatory Strategies and implementation plans for assigned projects, ensuring compliance with regulatory standards and facilitating the delivery of life-saving treatments.
BiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine
No H1B
Responsibilities
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
Qualification
Required
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
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
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
Benefits
Participation in Pfizer’s Global Performance Plan with a bonus target of 12.5% of the base salary
Participate in our share based long term incentive program
401(k) plan with Pfizer Matching Contributions
Additional Pfizer Retirement Savings Contribution
Paid vacation
Holiday and personal days
Paid caregiver/parental and medical leave
Health benefits to include medical, prescription drug, dental and vision coverage
Company
Pfizer
Pfizer is a biopharmaceutical company that discovers, develops, and delivers medicines and vaccines.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$38BKey Investors
Starboard Value
2025-11-21Post Ipo Debt· $6B
2024-10-07Post Ipo Equity· $1B
2023-05-16Post Ipo Debt· $31B
Leadership Team
Albert Bourla
Chief Executive Officer
Ian Read
Chief Executive Officer
Recent News
Springfield Business Journal
2026-02-04
2026-02-04
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