Regulatory Execution Hub Team Lead

Job Summary

The RIO Execution Hub Team Lead is responsible for leading the Hub Coordinators and Managers who provide regulatory support to the country and/or cluster Regulatory teams.

The Execution Hub Coordinators and Managers that report to this role, work across portfolio phases from initial applications, commercial lifecycle through to product withdrawal. They support numerous regulatory activities that include but are not limited to:

• M1 dossier components (local document authoring and/or coordination, including Labels & Artwork),

• Simple local only HA query responses,

• Provide Regulatory support for general x-functional support to local affiliates for tenders, out-of-stock reporting, Annual Product Quality Review, risk minimization communications, and coordination of regulatory input for launch planning.  

This role acts as the initial point of contact for assigned cluster/countries for issue resolution and escalation for the processes described above.

It is expected that this role partners closely with the RIO Submissions Hub Team Manager to enable timely, high-quality submissions and sustained compliance. This includes but is not limited to

• Identification of regulatory requirements identification (for the in-scope submission categories defined),

• Authoring, delivery and/or coordination of local, submission-ready documents and

• The quality review/approval of the Dossier provided by Hub Submission/Dossier Managers (for the in-scope submission categories defined).

In some regions/clusters, the RIO Execution Hub Team Lead can manage the Hub Submission Managers, while in others, RIO Execution Hub Team Lead should closely partner with Regional Submission Hub Team manager.

Job Responsibilities

Lead designated resources focused on end-to-end management of multi-regional, regional and national regulatory dossiers for assigned cluster/country, both initial applications and ongoing lifecycle through to product withdrawal. Associated functions are engaged to provide smooth operational performance and process efficiency.

This role supports implementation of the GRS mission by contributing to the definition and delivery against goals, executing initiatives, identifying and capitalizing on new opportunities, and filling gaps related to the production of regulatory International and operational support. A key component of this role is the proactive pursuit of portfolio execution efficiencies, identification of quality and compliance issues or emerging risks through establishment of methodologies to provide real time portfolio data.  Success in the role is expected to deliver measurable efficiencies for the organization.

Key Accountabilities include:

General accountabilities (For reference only)

• Lead RIO Execution Hub Coordinators & Managers to ensure timely delivery of local M1 dossier components

• Act as the initial point of contact for assigned cluster/country for issue resolution, escalation, and performance monitoring of the responsibilities under RIO Execution Hubs teams.

• Provide Regulatory support for general x-functional support to local affiliates for tenders, out-of-stock reporting, Annual Product Quality Review, risk minimization communications, and coordination of regulatory input for launch planning.

• Provide technical leadership for execution of local audit readiness activities including audit interviews as needed, Dear Healthcare Professional Communication (DHPC) responses, and responses to medical info requests as required.

• Oversee any input for country cross-functional meetings e.g., on launch plans as required.

• Oversee the Quality review/approval of the Dossier build Table of Contents provided by Hub Submission/Dossier Managers (for the in-scope submission categories defined).

• Oversee partnering with Growth submission managers and Regional Submission Hubs to deliver 

• • Growth applications to meet International Commercial knots prioritisation and Op plans.
• Support RIO and International Regional Leadership partnering with Submission Hubs for
  • International Commercial knot prioritisation discussions for Op plan cycle.
  • GRS lifecycle prioritisation discussions for CMC and Labelling changes

Local document authoring & submission prep (For reference only)

• Oversee the authoring and review of M1 local documents (cover letters, variations, MA applications), and relevant translations.

• Oversee engagement with Labeling Hubs and clusters/countries on Labels and Artwork updates to include local requirements, ensuring alignment with approved text and supporting launch activities.

• Oversee support to clusters/countries with authoring of simple HA query responses e.g., admin related requests, and coordinate with relevant SMEs/functions (e.g., CMC) to address more complex HA queries, based on CRS query response strategy.

People Leadership

• Foster a culture of performance, collaboration, and innovation while ensuring consistent capability development across the team.

• Drive team performance through effective goal setting, talent development, succession planning, and performance management.

• Create and sustain a high-performing team culture rooted in ownership, agility, and continuous improvement, within Pfizer values, behaviors and actionable attributes.

• Ensure operational readiness and adherence to compliance standards across systems, SOPs, training, and audit preparedness.

• Track and report operational performance against KPIs, quality metrics, and audit requirements.

In the case RIO team lead oversees the team of Hub Submission Managers (For reference only)

• Provide optimum operating model support associated with planning, development and delivery of the regulatory submission portfolio involving regional and national submissions to multiple Pfizer Country Clusters and regulatory authorities.

• Guide and advise Global Asset Teams on relevant guidance and policies related to publishing, document links and requirements for format construction and organization of dossier build.

• Oversee the execution and quality control of cluster/country submission management & publishing activities, such as formatting & publishing submissions in required formats (e.g., eCTD, paper, NeeS).

• Review and quality control of published outputs to confirm completeness and compliance.

As a key leader within the RIO organization, this role supports Pfizer mission by setting goals, executing initiatives, identifying, and capitalizing on new opportunities, and mitigating against all known risks related to successful execution. Success in the role will deliver against Pfizer goals and milestones for the entire portfolio, with emphasis on meeting or exceeding expectations for accelerated assets.

Qualifications/Skills

• Education to masters level e.g. MS, MBA in a scientific, technical or information management discipline required, although relevant professional experience will be considered
• An understanding of global, region and/or cluster regulatory requirements and trends is essential
• Proven leadership experience in Regulatory Strategist and/or Regulatory Operations
• Demonstrates sound Business Judgment and Acumen
• Deals with Ambiguity; Creativity; Ability to Adapt in Real-Time
• Command Skills; Directing Others; Conflict Management
• Strong Communication and Relationship-Building Skills
• Drive for results: Planning, Managing & Measuring work
• Business Change Management Methodologies and Implementation
• Accountable for creating an environment where continuous improvement and innovation are embedded in daily operations
• Develops and fosters communities of practice and culture of inclusion
• Commitment to leadership, diversity and talent development
• Robust understanding of biopharmaceutical industry, regulatory and safety processes, external/internal environment
• Possession of high energy level; sense of urgency; decisiveness, ability to work hard and well with high work volume
• Submission & Portfolio Management: Demonstrated experience leading others to deliver a complicated portfolio across multiple markets
• Technical Expertise (Essential): Demonstrated knowledge of / experience with strategic business planning and operations
• Communications Skills (Essential): Ability to communicate complex information and analyses, and difficult messages, to a variety of audiences in both verbal and written format
• Business Perspective (Essential): Cross functional, Global perspective within the context of business needs and impact.  Must have demonstrated business acumen; strong organizational management skills, the ability to handle multiple demands simultaneously; the ability to respond to tight timelines; as well as the capability to interact with all levels of the organization in a professional and discrete manner
• Managing the Organization (Essential): Demonstrated experience in support of large change programs involving x-site teams and perspectives (people, project and portfolio based).  Ability to mobilize resources at short notice, and operate as a clear decision maker
• Understanding of cultural norms and ability to successfully adapt style to collaborate with leaders and colleagues from multiplecountries a critical aspect of this role

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

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