WHY PATIENTS NEED YOU
GRS seeks to establish sustainable processes and a fit-for-purpose operating model to deliver Lifecycle Maintenance (LCM) activities for Pfizer’s mature portfolio. The GRS LCM Transformation Lead will design and launch the new operating model and processes, and will measure and communicate the success of the intiative. In partnership with cross-functional subject-matter experts across therapeutic-area regulatory strategy, CMC strategy, and labeling, the Lead will identify and implement continuous improvements in support of GRS’s LCM vision:
Streamlining processes to introduce new and more effective ways of working
Piloting new operating models, including introducing opportunities in lower-cost locations, where appropriate, to further optimize our geographic footprint.
Regularly assessing the mature portfolio and operating model to remain agile in response to changes in demand and priorities
Maintaining alignment with and benefits from the GRS Digital Transformation, e.g. use of AI.
This 6-month secondment which is estimated to be a 50-75% time commitment will manage the implementation of the LCM transformation (e.g., introduction of new ways of working and optimizing resource allocation within the current organizational structure through Q1 2026) and evaluate and recommend further changes to be implemented in Q2 2026 and beyond.
HOW YOU WILL ACHIEVE IT
Lead the implementation of a fit-for-purpose operating model that aligns with GRS’s LCM vision
Partner with GRS subject matter experts across therapeutic-area regulatory strategy, CMC strategy, and labeling to pilot new ways of working as well as identify and implement continuous improvements including streamlining workflows, introducing innovative practices, and digital tools
Maintain the master list of products in-scope for the GRS LCM transformation and establish the process for regularly evaluating mature products to remain responsive to evolving business needs and regulatory priorities
Define success metrics, track progress, and communicate outcomes to GRS leadership and key stakeholders, ensuring transparency and accountability.
Champion the business case and value story associated with the GRS LCM transformation and related decisions from a regulatory and business perspective
Build and maintain strong relationships with key stakeholders (e.g., Commercial, PGS) to both understand and inform portfolio decisions
Serve as the GRS point of contact representing GRS for other LCM initiatives across the enterprise
Support LCM governance decisions to ensure effective cross-functional support for mature products
QUALIFICATIONS
Must-Have
Education
Bachelor's degree required
Advanced academic qualifications/degree such as MBA or PhD an advantage but not essential.
Experience & Technical Skills
BA/BS with 12+ years of experience in pharmaceutical regulatory affairs.
Hands-on experience in the development of regulatory submissions globally and regionally in global pharma environment.
Proven leadership in managing post-approval submissions across CMC, non-CMC, labeling, and artwork, with strong understanding of cross-functional impacts.
Deep knowledge of U.S. and EU regulations for lifecycle maintenance of medicines and vaccines.
Skilled in interpreting and applying global/local regulatory guidance, especially in post-approval stages.
Strong cross-functional collaboration and relationship-building in global as well as matrixed settings.
Excellent project management, communication, negotiation, and problem-solving skills.
Ability to assess submission interdependencies and risks, advising stakeholders accordingly.
Effective communicator with strong influencing and negotiation capabilities in matrixed environments.
Collaborative team player with active listening and decision-making confidence.
Demonstrated ability to lead through ambiguity, change, and organizational transformation.
Skilled in time management and multitasking across concurrent projects.
Consistently fosters teamwork and leads solution-oriented group efforts.
Makes sound decisions in ambiguous or time-constrained situations by leveraging broad insights.
Fluent in English.
Nice-to-Have
MBA/MS with 10+ years of experience; OR PhD/JD with 7+ years of experience.
ORGANIZATIONAL RELATIONSHIPS
This role will liaise with other department functions and administrative staff where appropriate and requires engagement with a variety of stakeholders across Pfizer organizations.
RESOURCES MANAGED
Manages Pfizer colleagues and vendors as needed.
OTHER JOB DETAILS
Last Date to Apply for Job: October 1, 2025
Additional Location Information: UK - Sandwich, UK - Walton Oaks, CT - Groton, IL- Lake Forest, NY - Pearl River, United States - Any Pfizer Site, United States - Remote
Eligible for Relocation Package – NO
Secondment 6 months
If you are currently in a driving position with a fleet vehicle and this secondment does not require driving as an essential function of the position for 12 months or longer, you will be required to turn in your fleet vehicle for the duration of the non-driving secondment. Please refer to the Fleet Policy and Procedures document for more information.
There will be no change to your current work location.
Note: This secondment offers a valuable opportunity for professional growth. It will need to be funded by the secondee’s home market.
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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Continuous Imprv and Proj Mgmt
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