LCM Transformation Lead (Secondment - 6 Months)

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 RELAT