Regulatory Submission Lead - SDE LCM

*Only candidates with 5 years or more of experience with a strong understanding of industry, drug development, and R&D processes will be considered.

Working Model:

GSK supports hybrid working through our Performance with Choice model. This position is based in-office 3 days per week at Mississauga , Ontario, with flexibility to work remotely the remaining days.

Details (Your Responsibilities):

The Regulatory Submission Lead is responsible for independently supporting regulatory submission activities, including authoring, reviewing, providing Regulatory registration requirements and compiling dossiers for assigned deliverables in compliance with health authority regulations and GSK policies and processes. The position holder works with the Submission teams, Local Operating Company contacts, Global Regulatory Strategy or Functional Teams (or equivalent) to coordinate and prepare submission packages within the Veeva Vault system.

 

The position holder will also include mentoring and training new team members.

• Responsible for independently delivering assigned submissions as per agreed dossier strategy to the Submission teams, Local Operating Company contacts, Global Regulatory Strategy or Functional Teams (or equivalent), by working collaboratively with functional teams (e.g., CMC, Clinical, Nonclinical, etc.) & ensuring adherence to established timelines in assigned markets.
• Simultaneously oversees, multiple project assignments, including Variations (CMC and Therapeutic), PBRER, Renewals, Site Registrations/Site Renewals, Tenders of more complexity.
• Manage complex regulatory registration requirements, including those requested directly from regulatory agencies, manufacturing sites or third-party service providers. This includes providing manufacturing site support to meet regulatory expectations.
• Independently prepare, coordinate and ensure timely delivery of documents requested from health authorities, legalisation providers, manufacturing sites or third parties.
• Collaborates with staff across various functions and demonstrates the ability to engage with senior-level process development teams by providing advice, interpreting relevant guidelines, conducting research, and resolving complex issues. Possesses comprehensive knowledge of GSK processes and workflows, offering training, consultation, and tailored solutions both within and beyond the department.
• Ensure alignment with a comprehensive understanding of regulatory requirements, legislation, and guidelines for EU, US, and ROW markets, including Regulatory registration requirements. Independently perform data assessments to confirm that the dossier meets all necessary standards and is fit for purpose.
• Responsible for conducting scenario planning for multiple regulatory strategies and recommending delivery approaches to support accelerated timelines when needed. Proactively escalates business-impacting issues and suggests potential solutions.
• Serve as a reviewer for peers deliverables and propose improvements to regulatory processes, policies, and systems, thereby driving efficiency & innovation.
• Engage with Regulatory Agencies to address and resolve issues within their areas of responsibility.
• Demonstrates a strong understanding of regulations, guidelines, procedures and policies relating to registration and manufacturing of pharmaceutical products, to expedite submission, review and approval of global applications.
• Communicate effectively with internal and external GSK stakeholders on project- and policy-related matters with minimal managerial supervision, ensuring the best outcomes for the organization.

Why you? 

Preferred Qualifications:

·         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.

*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 CAD74,775 to CAD124,625 , 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 canada-recruitment@gsk.com.  Please do not send resumes to this e-mail and instead apply through the online application process of this posting.

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