GSK
Biopharma
RegionalRegulatoryManager
Neural analysis suggests this role is
optimal for Mid candidates.
“Regional Regulatory Manager at GSK. Skills: regional regulatory strategy, submissions and approvals, stakeholder alignment, risk assessment. Lead the development and execution of regional regulatory strategy for assigned assets, aligned with global strategy and regional requirements. Act as the single point of contact for regional regulatory, ensuring alignment across Global Regulatory Leads (GRLs), local regulatory teams, and cross‑functional stakeholders”
What You'll Achieve.
deliver the best possible labelling; enable right pace and alignment in project planning and execution; development of optimal regional regulatory strategy and for its delivery according to plan; deliver best-in class regulatory strategy; achieve the cross‑regional alignment and regional objectives
Industry & Context.
decision‑making and problem‑solving skills with ability to assess regulatory impact; Proven ability to manage complexity, anticipate risks, and drive solutions
What They're Looking For.
Must Have
Bachelor's Degree in Biological or Healthcare Science, experience in regional regulatory strategy, submissions, and approvals, Knowledge of clinical development, regulatory requirements, and agency processes, Ability to work cross‑functionally and influence stakeholders in a matrix environment, decision‑making and problem‑solving skills with ability to assess regulatory impact, Proven ability to manage complexity, anticipate risks, and drive solutions, Digital fluency and ability to leverage tools to enhance delivery and efficiency
Nice to Have
PhD in Biological or Healthcare Science, Experience of all phases of the drug development process in regulatory affairs preferred
What You'll Do.
Lead the development and execution of regional regulatory strategy for assigned assets
aligned with global strategy and regional requirements
Act as the single point of contact for regional regulatory
ensuring alignment across Global Regulatory Leads (GRLs)
local regulatory teams
and cross‑functional stakeholders
Provide regulatory expertise and market insight to anticipate risks
identify opportunities
and support decision‑making
Drive delivery of submissions and approvals
compliant execution across the region
Collaborate with global and local teams to integrate regional requirements into development plans
and submission strategies
Ensure clear communication of regulatory plans
and strategic implications to stakeholders
Support continuous improvement
and knowledge sharing across regulatory teams
How You'll Work.
Team & Collaboration
close collaboration and alignment with respective Global Regulatory Lead (GRL), Local Operating Company Regulatory Affairs (LOC RA) and Regional Medical & Commercial Leads; continuous engagement with LOCs, GRLs and regional stakeholders; matrix working with support from the Regional Regulatory Leads; liaison between GRLs, Medical, and Regional Commercial Leads, as well as the (LOC RA) in region; Collaborate with global and local teams
Communication Scope
Ensure clear communication of regulatory plans, milestones, risks, and strategic implications to stakeholders
Process & Methodology
project planning and execution, planning of given asset(s) will be on a multiple year horizon
Full Job Description
Ensure the development of appropriate business-focused, high-quality, timely regional regulatory strategy and its execution for assigned asset(s) consistent with relevant enterprise goals and respective product profile. This goal has to be achieved as a component of an overall global regulatory approach while ensuring compliance with both internal GSK process / policy and with regional regulatory requirements to deliver the best possible labelling, in a close collaboration and alignment with respective Global Regulatory Lead (GRL), Local Operating Company Regulatory Affairs (LOC RA) and Regional Medical & Commercial Leads. Being dedicated SPoC for given asset(s), the Regional Regulatory Manager keeps continuous engagement with LOCs, GRLs and regional stakeholders to enable right pace and alignment in project planning and execution. Responsible for the development of optimal regional regulatory strategy and for its delivery according to plan. In conducting role, planning of given asset(s) will be on a multiple year horizon, with delivery requiring matrix working with support from the Regional Regulatory Leads. The Regional RA Manager is the regional single point of contact on assigned asset(s), accountable for liaison between GRLs, Medical, and Regional Commercial Leads, as well as the (LOC RA) in region with the goal to deliver best-in class regulatory strategy, achieve the cross-regional alignment and regional objectives. We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme. We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work. Discover more about our company wide benefits and life at GSK on our webpage [_Life at GSK | GS
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