Responsable mondial des affaires réglementaires – CMC / Global Regulatory Affairs CMC Manager

GlaxoSmithKline; Quebec; On-site; CAD 90,000 - 120,000; Full time

Job summary

A global biopharma company is seeking a CMC Manager for their Quebec City office. This role involves managing CMC regulatory activities for GSK products, ensuring compliance with regulations, and working within cross-functional teams. The ideal candidate will have a strong background in regulatory affairs, particularly in biologicals and vaccines, along with excellent communication and project management skills.

Qualifications

• Experience in CMC regulatory affairs / Technical Life Cycle Management, preferably with biologicals / vaccines.
• Knowledge of regulatory procedures / systems / guidance.
• Ability to manage multiple tasks and identify priorities.

Responsibilities

• Responsible for global CMC regulatory activities for assigned projects.
• Develop CMC strategy for submission documents supporting product lifecycle management.
• Ensure regulatory compliance and engage in subject matter expert activities.

Skills

Quality mindset

Excellent communication skills

Time management

Education

Bachelor’s degree (Life Sciences background)

Job description

EN version to follow FR

Qualifications

Are you passionate about chemistry, manufacturing, and controls (CMC) for Regulatory Affairs? Our Quebec City office is looking for a manager who is excited by opportunity to apply their skills to the Vaccine site.

Job Purpose :

You would be responsible for the CMC regulatory activities in the late phase development and / or commercial lifecycle management of GSK products.

Details (Your Responsibilities) :

• Responsible for the global CMC regulatory activities for assigned projects and responds readily to changing events and priorities.
• Responsible for CMC strategy development, with managerial support, for CMC submission documents to support marketed product lifecycle management activities in accordance with the applicable regulatory & scientific standards.
• Understands, interprets, and will advise teams on regulations, guidelines, procedures and policies relating to manufacture and control of medicinal products, to expedite the submission, review and approval of global CMC applications.
• Ensures all appropriate CMC regulatory aspects for product release are in place, to ensure continuity of market supply. Ensures information submitted for lifecycle maintenance submissions meets regional requirements, allowing maximum Supply / Production / Quality flexibility with minimal unanticipated questions.
• Works in cross-functional matrix project teams, which include colleagues from regulatory, development, quality and manufacturing ensuring adequate interaction and partnership in order to define proper regulatory CMC filing strategy.
• Maintains high quality standards and seeks to raise levels of performance through continuous improvement and an innovative approach in responding to the evolving regulatory environment.
• Ensures regulatory compliance is maintained and sharesbest-practices and learnings within the CMC Regulatory teamsand other impacted functions.
• Engages inCMCSubject Matter Expert activities internally (for increased compliance,harmonisationand efficiency).
• Will deliver CMC regulatory strategy to support major inspections (egPAIs) with managerial support.

Qualifications

Why you?

Education

• Bachelor’s degree (Life Sciences background) or equivalent by experience.

Knowledge

• Knowledge of regulatory procedures / systems / guidance’s
• Knowledge of Technical Regulatory Life Cycle Management
• Knowledge of biological products
• Advanced level of English and intermediate level of French is required for this position as the incumbent will be working with global teams and external stakeholders daily that do not speak French.

Experience

• CMC regulatory affairs / Technical Life Cycle Management, preferably with biologicals / vaccines, proven ability to manage typical regulatory activities, resolve problems and deliver results.
• CMC authoring of CMC technical variations and Module 3 components, , preferably with biologicals / vaccines,
• Project Management
• Change control process
• Working within Biologics / vaccines environment preferred
• Managing submissions in EU, US and major regulatory markets preferred

Skills

• Quality mindset - Ensure rigorous scientific content / quality / compliance of documents intended for regulatory submissions.
• Manages own time to meet agreed short-term targets. Ability to clearly identify priorities and manage multiple tasks
• Excellent communication skills as you will be working with all levels of the organization as well as key external stakeholders.
• Please note this role does not have any direct reports, however you will be managing various projects.

Why GSK?

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

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory / immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

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 [emailprotected] .Please do not send resumes to this e-mail and instead apply through the online application process of this posting.

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