Regulatory Submission Manager

GSK

7d•Hybrid

About The Position

The job holder is responsible for managing end-to-end regulatory lifecycle submissions across multiple markets, ensuring timely delivery and compliance with regulatory authority requirements, guidance and GSK processes, including written standards. The role coordinates with cross-functional teams to execute lifecycle management activities, mentors and develops team members, and enforces Regulatory registration requirements, to maintain regulatory compliance and support GSK’s global product strategy. This role involves serving as a Subject Matter Expert to address escalations and drive improvements in regulatory processes, supporting organizational objectives and ensuring compliance with global regulatory standards This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: Own end‑to‑end delivery of assigned complex lifecycle regulatory submissions (e.g., variations, PBRERs, renewals, site registrations/renewals, tenders, etc.), ensuring they meet agency requirements, agreed dossier strategies and timelines while proactively managing risks and remediation. Provide peer review and quality assurance of deliverables; support authors on complex or non‑routine assignments. Lead drafting, authoring and technical review of complex, multi‑market dossiers to deliver high‑quality, compliant submissions that adhere to GSK standards and regulatory guidance. Apply subject-matter expertise to lead and mentor the team, enhancing capabilities in regulatory strategy, excellent authoring, and consistent adherence to SOPs and Work Instructions. Develop and sustain collaborative cross‑functional relationships with internal and external GSK stakeholders like manufacturing sites, regulatory authorities or third-party service providers to coordinate submission deliverables, address concern, resolve issues and implement fit‑for-purpose regulatory strategies. Drive continuous improvement and system innovation by defining and tracking key metrics, optimising processes and acting as the escalation point for submission issues affecting timelines or market access.

Requirements

Preferably more than 8 years relevant regulatory/submission experience.
In-depth knowledge of regulations, guidelines, and policies for pharmaceutical and vaccine registration and manufacturing.
Ability to interpret regulations and gain consensus on a way forward in an environment where there may be more than one way of achieving a successful outcome.
Ability to effectively interact with line and middle management, staff and external contacts on a functional and strategic level in a matrix environment.
Ability to think flexibly in order to meet constantly shifting priorities and timelines.

Nice To Haves

Excellent written and verbal communication skills and ability to present information in a clear and concise manner.
Excellent organisational skills, attention to detail and commitment to deliver high quality output, even under pressures sometimes demanded by regulatory deadlines.
Project management experience in the pharmaceutical industry or in a regulatory environment including knowledge of project management tools.
Ability to lead in a matrix environment and ensure delivery of objectives across cross-functional teams.
Ability to proactively identify and mitigate risks and potential bottlenecks, apply sound judgement when determining if/when to escalate issues, and effectively interact with stakeholders to ensure transparency of submission progress/status.
Ability to lead or co-lead multidisciplinary team meetings and facilitate discussions regarding submission content, timelines, resource allocation, risk management

Responsibilities

Own end‑to‑end delivery of assigned complex lifecycle regulatory submissions (e.g., variations, PBRERs, renewals, site registrations/renewals, tenders, etc.), ensuring they meet agency requirements, agreed dossier strategies and timelines while proactively managing risks and remediation.
Provide peer review and quality assurance of deliverables; support authors on complex or non‑routine assignments.
Lead drafting, authoring and technical review of complex, multi‑market dossiers to deliver high‑quality, compliant submissions that adhere to GSK standards and regulatory guidance.
Apply subject-matter expertise to lead and mentor the team, enhancing capabilities in regulatory strategy, excellent authoring, and consistent adherence to SOPs and Work Instructions.
Develop and sustain collaborative cross‑functional relationships with internal and external GSK stakeholders like manufacturing sites, regulatory authorities or third-party service providers to coordinate submission deliverables, address concern, resolve issues and implement fit‑for-purpose regulatory strategies.
Drive continuous improvement and system innovation by defining and tracking key metrics, optimising processes and acting as the escalation point for submission issues affecting timelines or market access.