RIO Execution Hub (EH) Manager, Sr. Manager

Pfizer; Makati; On-site; PHP 2,500,000 - 4,000,000; Full time

Job summary

Pfizer in Makati, Philippines, seeks an EH Manager, Sr. Manager to drive regulatory submissions and lifecycle management for designated countries and regions.

You will lead complex dossier preparation, coordinate with CRS, ILA, and other stakeholders to ensure timely, compliant submissions and high-quality outputs. The role requires strong project management, regulatory operations expertise, and a proactive approach to process improvement and digital tool adoption.

Qualifications

• Bachelor’s degree in Pharmacy or Life Sciences required.
• Minimum 5+ years in regulatory operations for Manager, 7+ years for Sr. Manager.
• Fluent English; multilingual skills desirable.

Responsibilities

• Lead and coordinate regulatory submissions for assigned products.
• Authors and reviews local dossier components and QA.
• Coordinate with cross-functional stakeholders to meet timelines.
• Identify opportunities to improve regulatory processes and digital tools.

Skills

Regulatory operations

Project management

MS Office

Stakeholder collaboration

English fluent

Education

Bachelor’s degree in Pharmacy/Life Sciences/Business/IT

Master’s degree (desirable)

Tools

Regulatory software

Document management systems

Job description

Job Summary

The EH Manager, Sr. Manager is responsible for providing operational regulatory support for designated countries, clusters and/or regions. This role supports submission logistics and technical aspects, ensuring development and delivery of X-regional, regional and/or national regulatory dossiers from initial application and subsequent lifecycle updates, guaranteeing regulatory compliance throughout the submission process. It is expected that this role partners closely with the Country Regulatory Strategist (CRS), International Labeling & Artwork (ILA) and other relevant stakeholders as required, to enable timely, high-quality submissions and sustained compliance. This includes but is not limited to: Planning regulatory submission timelines ensuring regulatory systems are up to date. M1 dossier components (authoring, delivery and/or coordination of local, submission-ready documents), excluding labeling and artwork components. Simple local only HA query responses authoring. Promptly escape any submission plan delays and develop mitigation strategies aligned with the assessed impact and associated risks The quality review/approval of the Dossier structure for applicable submissions, when required. Provide support for general x-functional activities to country Regulatory teams for tenders, out-of-stock reporting, Annual Product Quality Review, risk minimization plans, and coordination of regulatory input for launch planning. Identify opportunities to streamline the end-to-end regulatory process, applying digital tools when applicable. Given the global span of the organization, critical features of this role require strong project management, regulatory operations expertise & digital skills, and the ability to collaborate effectively across diverse cultures, functions, and geographic regions. The individual serves as a trusted partner to global, regional, cluster and local stakeholders, ensuring the timely delivery of high-quality regulatory submissions and operational regulatory support that enables patient access and business objectives.

Job Responsibilities

General responsibilities: Leads and coordinates from moderate to complex regulatory submissions (Growth & complex lifecycle) for assigned products aligned with business priorities and needs. Accountable for delivering designated tasks with quality and timely as per applicable policy, SOP/Work Instructions, guidelines, or service level agreement. Authors, reviews, and maintains local regulatory documents (Module 1 dossier components) for the submission categories / markets or products assigned. Manages and coordinates components receipt, translation management, dossier compilation, local ancillary legalization, and submission readiness to facilitate timely Health Authority submissions. Tracks and develops action plans to maintain or improve operational performance against portfolio management, data health, KPI, quality metric, and audit requirement targets for the markets/clusters under responsibility. Ensures the timely delivery of high-quality regulatory submissions and dossier components, monitoring them against milestones to meet business-critical timelines and regulatory requirements. Manages the authoring of simple HA query responses e.g., admin related requests, and coordinates with relevant SMEs/functions to address more complex HA queries, based on CRS query response strategy. Coordinates support to tenders, out-of-stock reporting, Annual Product Quality Reviews, local audit readiness, risk minimization activities, Dear Healthcare Professional Communications (DHPCs), responses to medical information requests and other regulatory operational activities. Partners with cross-functional stakeholders and third party partners to ensure successful delivery of regulatory priorities and operational plans. Escalates and communicates issues that may impact submission timelines, quality, compliance, or business commitments, including the timely identification, escalation of Quality Events affecting their processes, deliverables, or areas of responsibility. Maintains required training curricula and demonstrates continued proficiency in regulatory processes, submission requirements, tools, and systems. Actively identifies, evaluates, and implements opportunities to improve submission processes, regulatory operations workflows, and dossier execution efficiencies at the local, regional, and global levels. Functions as a change agent that can exhibit regulatory knowledge and awareness, technical competence, sound judgment, and a professional demeanor. Lead or contribute to projects impacting people, processes, technology, and operational excellence across RIO and GRS. Partner with global colleagues and key stakeholders to support critical, high-priority, and accelerated submissions, ensuring successful execution against regulatory and business objectives. Leads project management activities for regulatory submissions, including development of timelines, work plans, deliverables, risk assessments, and mitigation strategies. Monitors’ submission progress and proactively identify, elevate, and resolve issues impacting quality, compliance, resource requirements, or regulatory timelines and support of CAPAs for Quality Events affecting their processes, deliverables, or areas of responsibility. Represents regulatory operations in project meetings, advocating realistic deliverables, communicating risks, and providing status updates on submission activities. Contributes to forecasting and resource planning activities, supporting flexible resourcing and global workload sharing to optimize delivery of regulatory commitments. Drives adoption of standardized document authoring, publishing, document management, and archival processes to improve quality, compliance, and operational effectiveness. Applies advanced regulatory and operational knowledge to deliver business outcomes across complex projects and regulatory initiatives. Demonstrates critical thinking and sound judgment when balancing quality, compliance, risk, and speed in a dynamic regulatory environment. Supports the development of digital and automation solutions that simplify regulatory processes, improve operational efficiency, optimize resource utilization, and support continuous improvement across regulatory operations. Leads discussions for complex regulatory projects and ensure alignment of submission strategies across global, regional, and local stakeholders. Cultivates a culture of continuous learning, digital fluency, innovation, collaboration, and operational excellence through the adoption or leadership for development of digital solutions, proactive problem-solving, and strong stakeholder engagement.

Qualifications / Skills

Qualifications: Bachelor’s degree (or equivalent) in Pharmacy, Life Sciences, Business or Information Technology (desirable) required, with a minimum of 5+ years for Manager and 7+ years Sr. Manager. Education to master’s level (desirable) e.g. MS, MBA in a scientific, technical or information management discipline required, although relevant professional experience will be considered. Fluent English language required. Multilingual skills desirable (including Portuguese in LatAm EH). Proven technical aptitude and ability to quickly learn and use new software, regulations and quality standards. Advanced Microsoft Office Suite skills. Familiarity with pharmaceutical organizational structures, systems, and culture is preferred. An understanding of country/cluster regulatory requirements and trends is preferred. Relevant experience within pharma, in Regulatory, quality and/or compliance fields preferred. Effectively leverages approved AI solutions to enhance individual productivity, decision-making, process execution, and operational efficiency. Skills: Manager: Demonstrates deep regulatory operations knowledge and technical expertise to effectively act as SME of regulatory submission and lifecycle management activities. Demonstrates leadership and decision-making autonomy within area of responsibility, effectively guiding teams through medium-to-complex regulatory and operational challenges. Actively contributes to regional and global initiatives across RIO, GRS, and CMO organizations, collaborating with cross-functional stakeholders to drive business objectives, process improvements, and organizational transformation. Quickly learns and applies regulatory processes, systems, tools, and procedures to deliver high-quality work within established timelines and compliance requirements. Builds strong collaborative relationships and communicates clearly and effectively across functions, teams, and stakeholders. Facilitates productive discussions, aligns stakeholders around common objectives, and delivers messages tailored to audience needs and business priorities. Leads to the successful completion of project and team deliverables through collaboration, attention to detail, and effective execution of assigned responsibilities. Demonstrates agility and adaptability in a dynamic regulatory environment, balancing quality, compliance, and business priorities. Maintains a strong commitment to compliance, quality, continuous learning, and operational excellence. Applies critical thinking and sound judgment to evaluate options, assess risks, and make informed decisions that support project and business objectives. Deals with Ambiguity; Creativity; Ability to Adapt in Real-Time. Drive for results: Planning, Managing & Measuring work. Senior Manager (cumulative from above): Proven advanced regulatory operations and submission management expertise, applying technical knowledge to support the successful execution of complex regulatory activities and submissions. Independently identifies, analyzes, and resolves complex issues, navigating ambiguity and determining when escalation or broader stakeholder engagement is required. Proven proficiency in regulatory systems, workflows, and document management tools, with the ability to quickly learn and apply new technologies, processes, and standards. Effectively plans, prioritizes, and manages multiple projects and competing deadlines while maintaining high standards of quality, compliance, and customer focus. Ability to communicate complex information, analyses, and difficult messages with clarity and impact to diverse audiences in both verbal and written formats. Influences and engages stakeholders through strategic communication, translating complex concepts into actionable insights, driving alignment across teams and markets, and effectively leading communications during change and transformation initiatives. Possession of high sense of urgency; decisiveness, ability to work hard and well with high work volume. Cultivates influential partnerships across global, regional, and local stakeholders, driving alignment across teams and markets, and successful execution of cross-functional priorities.

Equal Opportunity Statement

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. Regulatory Affairs Pfizer careers are like no other. In our culture of individual ownership, we believe in our ability to improve future healthcare, and potential to transform millions of lives. We’re looking for new talent to join our global community, to unearth new innovative therapies that make the world a healthier place.