The EH Associate, Sr. Associate 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 escalate 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.
Responsibilities:
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.
Associate:
- Manages and coordinates lower complexity regulatory activities for assigned products and/or at required dossier execution process workflow as appropriate.
- 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.
- Coordinates components receipt, translation management, dossier compilation, local ancillary legalization, and submission readiness to facilitate timely Health Authority submissions.
- Ensures the timely delivery of high-quality regulatory submissions and dossier components, monitoring them against milestones to meet business-critical timelines and regulatory requirements.
- Supports authoring of simple HA query responses e.g., admin related requests.
- Provides 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.
- Supports continuous improvement initiatives and contributes to projects that enhance regulatory operational excellence, scalability, efficiency, and compliance across the organization.
- Serves as a subject matter expert for assigned processes, products, regions, or regulatory operational activities, as appropriate.
Senior Associate (cumulative from above):
- Leads and coordinates lower to medium complexity regulatory activities for assigned products and/or at required dossier execution process workflow as appropriate.
- Coordinates with relevant SMEs/functions to address more complex HA queries, based on CRS query response strategy.
- 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, escalate, 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.
- Actively identifies, evaluates, and implements opportunities to improve submission processes, regulatory operations workflows, and dossier execution efficiencies at the local, regional, and global levels.
- 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 discussions for lower to medium 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 of digital solutions, proactive problem-solving, and strong stakeholder engagement.
Qualifications:
- Bachelor’s degree (or equivalent) in Pharmacy, Life Sciences, Business or Information Technology (desirable) required, with at least 2 years for Associate and 3+ years for Senior Associate.
- 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.
Skills:
Associate:
- Demonstrates foundational regulatory operations knowledge and technical expertise to effectively execute assigned regulatory submission and lifecycle management activities.
- Works effectively under guidance and management oversight while progressively building independence and technical proficiency.
- Quickly learns and applies regulatory processes, systems, tools, and procedures to deliver high-quality work within established timelines and compliance requirements.
- Communicates clearly and effectively, both verbally and in writing, delivering impactful presentations mainly to internal teams.
- Contributes 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.
- Utilizes approved AI-enabled tools to improve productivity, learning, document drafting, information analysis, and execution of daily work activities, while applying appropriate judgment and responsible AI practices.
Senior Associate (cumulative from above):
- Demonstrates advanced regulatory operations and submission management expertise, applying technical knowledge to support the successful execution of lower to medium complexity regulatory activities and submissions.
- Independently identifies, analyzes, and resolves moderately complex issues, navigating ambiguity and determining when escalation or broader stakeholder engagement is required.
- Demonstrates 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.
- Communicates complex information clearly and effectively to diverse stakeholders through strong verbal, written, leading impactful presentations to local, regional and global teams, and customer engagement skills.
- Demonstrates adaptability and resilience in a dynamic, fast-paced environment, embracing change and identifying opportunities for innovation and continuous improvement.
- Works with a high degree of independence under general supervision, taking ownership of deliverables, priorities, and outcomes.
- Partners effectively across global, regional, and local teams, building collaborative relationships and contributing to successful cross-functional execution.
- Effectively leverages approved AI-enabled tools to enhance productivity, streamline work processes, improve the quality of deliverables, and support data-driven decision making, while demonstrating responsible AI use and critical evaluation of AI-generated outputs.
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