Regulatory Submission Lead, SDE - LCM

Are you energized by a highly impactful regulatory affairs role that allows you to shape and accelerate regulatory effectiveness across the organization?  If so, this Regulatory Affairs Operations Manager role could be an ideal opportunity to explore. The Regulatory Submission Lead is responsible for independently supporting regulatory submission activities for assigned deliverables, ensuring compliance with health authority regulations and GSK policies. The role authors, reviews, compiles and delivers dossiers using Veeva Vault, collaborates with Submission teams, Local Operating Company contacts and Global Regulatory/Functional teams, and provides mentoring and training to new team members.

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following…

• Independently deliver assigned submissions according to agreed dossier strategy, collaborating with functional teams (CMC, Clinical, Nonclinical, etc.) and LOC contacts; ensure adherence to timelines in assigned markets.

• Oversee multiple simultaneous project assignments (e.g., CMC and therapeutic Variations, PBRER, Renewals, Site Registrations/Site Renewals, complex Tenders).

• Manage complex regulatory registration requirements from agencies, manufacturing sites or third-party providers, 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.

• Engage cross-functionally and with senior process-development teams to provide regulatory advice, interpret guidelines, conduct research and resolve complex issues.

• Provide training, consultation and tailored solutions within and beyond the department; possess comprehensive knowledge of GSK processes and workflows.

• Maintain alignment with regulatory requirements, legislation and guidelines for EU, US and ROW markets; perform data assessments to confirm dossier fitness-for-purpose.

• Conduct scenario planning for multiple regulatory strategies and recommend delivery approaches to support accelerated timelines; proactively escalate business-impacting issues and propose solutions.

• Act as a peer reviewer for deliverables and recommend improvements to regulatory processes, policies and systems to drive efficiency and innovation.

• Engage with regulatory agencies to address and resolve issues within area of responsibility.

• Demonstrate thorough understanding of regulations, guidelines, procedures and policies related to registration and manufacturing to expedite submission, review and approval of global applications.

• Communicate effectively with internal and external stakeholders on project- and policy-related matters with minimal managerial supervision.

• This role follows GSK’s "Performance with Choice" hybrid working model, combining regular on-site collaboration for stakeholder‑facing and team activities with flexible remote work for focused individual tasks and deliverables.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Bachelor’s degree or higher in biological or healthcare science

• 5 years of experience with strong understanding of the industry, drug development and R&D processes.

• In-depth knowledge of regulations, guidelines and policies for pharmaceutical and vaccine registration and manufacturing.

• Proficient in Veeva Vault for submission deliverables.

• Excellent organizational, communication and interpersonal skills; able to deliver high-quality results under tight deadlines.

• Skilled at interpreting global regulatory requirements and providing expert guidance informed by recent GSK experience.

• Adaptable and proactive in managing workload, priorities and timelines within a matrix environment.

• Proven ability to manage multiple projects concurrently and build strong internal stakeholder relationships.

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Master’s degree or MBA

• Experience working in a matrixed environment

• Demonstrated ability to engage and influence senior stakeholders.

Why GSK?

Our values and expectations are at the heart of everything we do and form an important part of our culture.

These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:

• Operating at pace and agile decision-making – using evidence and applying judgement to balance pace, rigour and risk.

• Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.

• Continuously looking for opportunities to learn, build skills and share learning.

• Sustaining energy and well-being.

• Building strong relationships and collaboration, honest and open conversations.

• Budgeting and cost-consciousness.

*This is a job description to aide in the job posting, but does not include all job evaluation details.

#LI-Hybrid

In compliance with Ontario's provincial pay transparency legislation, this job posting includes a salary range to support equitable and informed hiring practices. The annual compensation for this role is CAD82,000 to CAD132,000 , determined based on experience, qualifications, and internal equity. GSK is dedicated to promoting transparency and fairness throughout our recruitment process.Salary ranges for other locations are shown because some markets have pay transparency laws that require salary information on job postings, and those locations are potential job sites for this role. If salary ranges are not displayed in the job posting for a specific location or country, the relevant compensation will be discussed during the recruitment process.

Why GSK?
Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law. GSK is committed to accommodating persons with disabilities. If you need accommodation at any stage of the application process or want more information on our accommodation policies, please contact us at [email protected].  Please do not send resumes to this e-mail and instead apply through the online application process of this posting.

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