Job Detail

As a Regulatory Compliance Expert Pain Relief your main objective will be to coordinate activities with a regulatory impact on a portfolio of products by ensuring regulatory compliance during the lifecycle of the product, participating in projects evaluation and submission strategy.

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

• Responsible for planning the site’s regulatory activities for the products under his responsibility and for new developments projects. Collaborate with Central Regulatory on the establishement of planned activities (variations, renewals,…) and prioritization. Escalate potential issues or delays


• Ensure timely availability of documentation for planned regulatory submissions and RTQ, act as facilitator  between Central Regulatory and  plant technical functions (production, technical and analytical/stability departments) and collaborate with worldwide affiliates for regulatory compliance matters


• Evaluate regulatory relevance of proposed changes. Participate in change control process from creation, strategy and implementation until closure, represent regulatory point of view at the site’s Change Control Committee


• Identify and evaluate gaps as well as propose regulatory remediation and get escalation process under way in case of non-compliance


• Regulatory Compliance SME during audits and Health Authorities Inspections


• Elaborate SOP and WI for all processes related to team activities and daily tasks


• Evaluate Regulatory Compliance resources and budget for projects


• Coordinate ways of working with other departements and work on process improvement


• Onboard newcomers in team, provide training and supervision

Why you?

Basic Qualifications:

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

• Bachelor or Master In life Science or equivalent


• 5-7+ year in a Pharmaceutical Quality Environment


• Good experience in Regulatory Affairs/CMC


• Understanding of laboratory techniques


• Good understanding of GMP


• French: fluent (oral and written), good presentation skills


• English: fluent (oral and written), good presentation skills


• MS Office: good command


• M-ERP, Veeva, TrackWise, DIGA: good knowledge


• Team player, ability to analyse and attentive to details, good communication and influencing skills,  handling of priorities, adaptability ​

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.

*Li-GSK

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

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