Associate II Reg Strategy, GRS 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

In this role, you will collaborate with Global Regulatory Leads and product teams on lifecycle maintenance submissions and regulatory activities. You will represent a specific region (US, EM, or EU) and provide strategic expertise as part of the Global Regulatory Strategic Team, focusing on life cycle maintenance submission activities, CMC Module 1 document preparation, Safety compliance report and operational activities.

Key Job responsibilities

1. Regulatory strategy and lifecycle execution

·       Coordinate lifecycle activities, including variations, supplements, amendments, renewals, withdrawals, post-approval commitments and other maintenance submissions for assigned regions

·       Lead and implement regional regulatory strategies in agreement with key stakeholders for assigned projects/products and in line with the commercial goals.

·       Ensure regulatory positions and submission approaches are aligned across relevant global, regional and country stakeholders.

2. CMC submission operations and eAF CMC process

·       Author and QC electronic applications, cover letters, submission packages as requested by Strategist in support of life cycle maintenance of products

·       Perform quality checks of eAF CMC content for completeness, accuracy and alignment with the approved regulatory strategy and source documents.

·       Identify process gaps and contribute to simplification, automation and continuous improvement of eAF and CMC regulatory workflows.

3. Submission preparation and Health Authority support

·       Prepare, coordinate and quality-check submission components such as cover letters, application forms, response documents, commitments, declarations, product information and administrative documents.

·       Support responses to Health Authority questions by coordinating inputs, consolidating comments, checking consistency and ensuring delivery to agreed timelines and quality standards.

·       Collaborate with country and regional colleagues on submission requirements, and implementation activities.

4. Labeling, safety and aggregate-report support

·       Coordinate regulatory activities related to core and local labeling updates, including impact assessment, submission planning, implementation tracking and reconciliation.

·       Support submission and tracking of aggregate reports, risk-management documents and post-authorization safety or efficacy commitments, as applicable.

·       Generate Pearl reports, WWRS reports etc, in support of safety compliance report, Renewals, launches and                 

      health authority queries on need basis.

5. Cross-functional collaboration and team contribution

·       Build effective working relationships with Global Regulatory Leads, CMC Regulatory, clinical, safety, labeling, quality, supply, commercial, publishing and country regulatory teams.

·       Participate actively in project and regulatory sub-team meetings, clearly communicate decisions and follow through on assigned actions.

·       Provide activity-based support across products based on business priorities and team capacity.

·       Share knowledge, coach colleagues on established processes and contribute to a collaborative, accountable

Key Deliverables and Success Measures

On-time delivery

Assigned regulatory deliverables completed by agreed timelines, with early escalation of material risks.

Quality and accuracy

Submission components and eAF CMC data are complete, consistent and first-time-right, with minimal rework.

Compliance

Proper Input to safety compliance reports, maintaining activities tracker, systems and trainings,

Stakeholder partnership

Clear communication, timely follow-up and positive collaboration across global, regional and country teams.

Continuous improvement

Documented contribution to process simplification, standardization, automation or reusable team tools.

Basic Qualifications

·       Bachelor’s or master’s degree in pharmacy, or   life sciences, chemistry, biotechnology or a related discipline, with preferably relevant regulatory of 2 to 4 years pharmaceutical industry experience.

·       The ideal candidate possesses a strategic mindset, demonstrates agility in a rapidly evolving environment, and leverages insightful questioning, critical thinking, and data-driven assessment to develop sound, forward-looking regulatory strategies.

·       Working knowledge of pharmaceutical regulatory submissions and product lifecycle management.

·       Experience preparing, coordinating or reviewing regulatory submission documents and maintaining regulatory data or trackers.

·       Ability to manage multiple priorities in a complex global matrix environment with appropriate independence and attention to detail.

·       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)

·       Strong written and verbal communication skills, including the ability to communicate technical or regulatory information clearly to varied stakeholders.

Preferred Qualifications

·       Master's degree in pharmacy, regulatory affairs, life sciences or a related discipline.

·       Experience supporting oncology, specialty care, , biologics or other complex product portfolios.

·       Hands-on experience with post-approval variations, renewals, labeling changes, Health Authority responses or CMC submissions.

·       Experience with eAF, product data management, electronic submission tools, document management systems or regulatory information management systems.

·       Knowledge of major regulatory frameworks and submission procedures, including EM, EU and/or US requirements.

·       Experience applying process improvement, data analytics, automation or approved AI tools in a regulated environment.

·       Advanced education and practical experience, ensuring a well-rounded and capable professional

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers.