Regulatory Transformation Lead

2 weeks ago

Sandwich, United Kingdom Pfizer Full time

Job Summary

As Regulatory Process Transformation Lead, function as key driver of innovative thinking in Global Regulatory Operations and beyond, overseeing, connecting, and driving regulatory process innovation projects that will transform how regulatory works and delivers for the benefit of Pfizer and patients.

Work closely with Regulatory partners and stakeholders to (a) develop business innovation strategies as part of the GRS Digital Blueprint and (b) execute and deliver upon cutting edge, high impact transformative projects that create quantitative and/or qualitative value.

Job responsibilities
- Accountable for defining, aligning, and driving global Submission Management & Publishing needs within a OneGRS innovation program with a clear return on investment (e.g., reductions in cycle times and/or effort; increased User Experience; Simplification; use of data analytics) through bold transformation and incremental change programs.
- Function as thought partner and advocate across internal and external GRS, IM and digital colleagues and in support of GRS’s broader digital vision
- Design structures, operating procedures, and integrated working models to leverage digital technologies around highly productive human resources, freeing portfolio facing roles _e.g., CMC Change Managers and Submission Managers_, to advance strategic and complex portfolio work
- Oversee and guide individual Project owners to ensure project scope and purpose is consistent with GRS’s digital vision and priorities
- Collaborate with GRS, GRO and SM&P leaders and program sponsors as required to build consensus and support for organizational or role changes in response to emerging digital capabilities
- In support of the Blueprint Strategic Cluster Forum, lead a designated Cluster (e.g., Portfolio Planning) focused on the development of data strategies, tools, and business practices to digitalize GRS’s User Experience in support of regulatory strategy and portfolio execution.
- Partner with others to guide and accelerate the digital Blueprint priority projects by assuring appropriate linkages, connections, and delivery of expected milestones.
- Broad understanding and, where necessary, engagement with external partners to ensure alignment with developing regulations and the regulatory environment.
- Accountable for ensuring that:

- The expected outcomes for each program of work are clear, sustainable, and scalable, delivering long term, measurable value.
- All active projects include documented outcomes and deliverables that provide transparency and visibility to project including clear dependencies and alignment across related projects as well as near and long-term milestones identified.
- Projects do not have solutions which are beneficial for one project but cause issues for another.
- Teams are adopting best practice approaches to make rapid progress (e.g., Agile methodology if appropriate).
- Communication of progress and outputs to key stakeholders
- Coach, mentor and develop colleagues.

Qualifications and Skills
- Life sciences, pharmacy graduate or equivalent.
- Additional advanced academic qualifications (e.g., MS, MBA, PhD, and PharmD) highly desired. Equivalent relevant professional experience will be considered.
- Proven leadership experience in global/multi-national pharmaceutical environment, including direct experience either in Regulatory Submissions or Regulatory Sciences role dealing with health authorities.
- 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.
- Broad knowledge of GRS business objectives and processes supporting the development, regulatory strategy, regulatory submission, lifecycle maintenance.
- Experience with delivering collaborations across functions in GRS and with partner groups (e.g., clinical development, commercial, medical, Pharmaceutical Global Supply, safety).
- An open approach to innovation, with a progressive attitude to business development around the benefits of digitization.
- Understanding of the placement of digital tools within a human-centered oversight model.
- Demonstrated experience in problem solving and involvement in implementation of large-scale business process improvements.
- High interest and motivation to accelerate and progress digital business projects.
- Strategic leadership and team working skills to effectively engage with project leads, to encourage and support project alignment and delivery.
- Strong analytical skills and judgment to identify dependencies, issues for escalation, resolution of conflicts.
- Good organizational skills ensuring rapid and timely support for teams and meeting the fast-paced progression of project deliverab

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