Submission Lead

GSK•Mississauga, ON

5d•Hybrid

About The Position

The Regulatory Submission Lead independently manages regulatory submission activities—authoring, reviewing, and compiling dossiers and registration requirements for assigned deliverables in Veeva Vault—ensuring compliance with health authority regulations and GSK policies. The role coordinates with Submission teams, Local Operating Companies, and Global Regulatory/Functional teams, and mentors new team members.

Requirements

5 years of experience with a strong understanding of industry, drug development, and R&D processes.
In-depth knowledge of regulations, guidelines, and policies for pharmaceutical and vaccine registration and manufacturing.
Proficient in using Veeva Vault systems to ensure efficient and compliant submission deliverables.
Excellent organizational, communication, and interpersonal skills, with a focus on delivering high-quality results under tight deadlines.
Skilled in interpreting global regulatory requirements and providing expert guidance based on recent GSK experience.
Adaptable and proactive in managing workloads, priorities, and timelines while effectively collaborating in a matrix environment.
Proven ability to handle multiple projects simultaneously and build strong relationships with internal stakeholders.

Nice To Haves

Detailed knowledge of CMC (chemistry, manufacturing and controls) content requirements.
Experience working in a global, matrixed environment.
Demonstrated ability to engage and influence senior stakeholders.
Experience training or mentoring colleagues on submission processes.
Advanced degree in a scientific discipline or relevant professional certification.

Responsibilities

Deliver assigned submissions per dossier strategy, coordinating with Submission teams, LOCs and Global Regulatory/functional teams (e.g., CMC, Clinical) to meet agreed timelines in assigned markets.
Manage multiple complex projects concurrently (variations, PBRERs, renewals, site registrations/renewals, and complex tenders).
Handle complex registration requirements from agencies, manufacturing sites, or third parties, including providing site support to meet regulatory expectations.
Prepare, coordinate and ensure timely delivery of documents requested by health authorities, legalization providers, manufacturing sites or third parties.
Collaborate cross‑functionally and with senior process teams to advise, interpret guidance, research and resolve complex issues; provide training and tailored GSK process solutions.
Ensure dossiers meet EU, US and ROW regulatory requirements through independent data assessments to confirm fitness for purpose.
Conduct scenario planning for regulatory strategies, recommend accelerated delivery approaches, and proactively escalate business‑impacting issues with proposed solutions.
Review peer deliverables and drive improvements in regulatory processes, policies and systems to increase efficiency and innovation.
Engage with regulatory agencies to resolve issues within scope.
Apply deep knowledge of regulations, guidelines and manufacturing policies to expedite global submission, review and approval.
Communicate clearly with internal and external stakeholders on project and policy matters with minimal supervision to secure optimal outcomes.