JOB SUMMARY
The RIO Execution Hub Team Lead is responsible for leading the Hub 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 documentsThe 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
General Accountabilities :
Lead RIO Execution Hub Coordinators & Managers to ensure timely delivery of local M1 dossier componentsAct as the initial point of contact for assigned cluster / country for issue resolution, escalation, and performance monitoring of the responsibilities under RIO Execution Hubs teamsProvide 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 planningProvide 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 requiredOversee any input for country x-functional meetings e.g., on launch plans as requiredOversee 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 Grow submission managers and Regional Submission Hubs to deliver :Growth applications to meet International Commercial knots prioritisation and Op plansSupport 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 translationsOversee engagement with Labeling Hubs and clusters / countries on Labels and Artwork updates to include local requirements, ensuring alignment with approved text and supporting launch activitiesOversee 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 strategyPeople 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 oversee the team of Hub Submission Managers :
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 authoritiesGuide and advise Global Asset Teams on relevant guidance and policies related to publishing, document links and requirements for format construction and organization of dossier buildOversee 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 complianceAs 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 consideredAn understanding of global, region and / or cluster regulatory requirements and trends is essentialProven leadership experience in Regulatory Strategist and / or Regulatory OperationsDemonstrates sound Business Judgment and AcumenDeals with Ambiguity; Creativity; Ability to Adapt in Real-TimeCommand Skills; Directing Others; Conflict ManagementStrong Communication and Relationship-Building SkillsDrive for results : Planning, Managing & Measuring workBusiness Change Management Methodologies and ImplementationAccountable for creating an environment where continuous improvement and innovation are embedded in daily operationsDevelops and fosters communities of practice and culture of inclusionCommitment to leadership, diversity and talent developmentRobust understanding of biopharmaceutical industry, regulatory and safety processes, external / internal environmentPossession of high energy level; sense of urgency; decisiveness, ability to work hard and well with high work volumeSubmission & Portfolio Management : Demonstrated experience leading others to deliver a complicated portfolio across multiple marketsTechnical Expertise (Essential) : Demonstrated knowledge of / experience with strategic business planning and operationsCommunications Skills (Essential) : Ability to communicate complex information and analyses, and difficult messages, to a variety of audiences in both verbal and written formatBusiness 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 mannerManaging 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 makerUnderstanding of cultural norms and ability to successfully adapt style to collaborate with leaders and colleagues from multiple countries a critical aspect of this roleORGANIZATIONAL RELATIONSHIPS
Report to the Hub Lead.Interacts withCountry / Cluster teams, Submission Manager hubs and other functions across RIOGIPE, GRS broader organizationLocal affiliate cross functional teams that are Submission Content suppliers for M1 local components (e.g. Medical, Safety, Clinical, DRSD), Project Management, Legal, finance, informing or via the Country Regulatory team per agreements establishedRESOURCES MANAGED
Direct line management of Individual Contributors and / or Regional and / or functional line managers. (Up to 15)Other Information – Internal OnlyOther Information – Internal OnlyThis position holds a Global Job Level 090 / Senior ManagerLocation : UK / Europe - Any Pfizer SitePurpose
Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values : courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.
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Regulatory Affairs
