Job Detail

Site Name: Switzerland - Nyon

Posted Date: Apr 1 2021

The purpose of this role is to provide regulatory leadership, governance and expertise to one sub-category, brand or a portfolio of products such that our products are successfully introduced or maintained Globally.

As a Regulatory Affairs Category Manager you will build a network of collaborative relationships within the sub-category and LOCs and ensure all regulatory requirements are met for both new innovation and existing products according to GSK Values.

In this role you may also manage a small team for which they will set a compelling vision and deliver against the sub-category strategy and mission. The role may require you to provide specialist regulatory advice across the Category and Function.

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

• Acts as a Business Partner and provides regulatory advice across a brand or subset of products on aspects of drug/cosmetic/devices/food and supplements (dependent on category) development and regulatory requirements as appropriate.


• Develops novel regulatory strategies and influences approaches within Project Teams in order to secure competitive approvals and speed to market in conjunction with LOC regulatory teams.


• Communicates effectively within the function at all levels and within cross-functional Project Teams.


• May supervise or mentor other team members.


• Plans, prepares and delivers high quality regulatory files to agreed timelines.


• May lead non-product related activities within the function and input cross functionally, in order to direct new policy or pioneer new processes or improvements to GSK's competitive advantage.


• May act as GSK representative to external groups on specific task forces within their field of expertise.


• Support the development of the strongest claims possible aligned to consumer insight and within the regulations, ensuring risks are appropriately addressed and communicated within Project Team.


• In conjunction with the category regulatory CMC lead, ensure support for the full life cycle of products, including: maintenance activities; Design to Value, complexity reduction, value engineering initiatives; change controls, etc. with supply chain and technical excellence.


• Ensures compliance of their actions by adhering to global, regional and local processes, policies, SOPs and working instructions.


• Representation of GRA during audits with MDTF or Medical Devices Regulatory activities in scope.

Medical devices Accountabilities:

For Medical Devices (all classes according to 93/42/EEC as amended and Medical Device Regulation (EU) 2017/745 as amended) for which the Manager Regulatory Affairs Category is responsible or acting as back-up ensuring among others:

- Acting as a delegate for the Director Category Regulatory Affairs for the approval of technical files together with the Legal Manufacturer representative.

- Approval and Signature of Declaration of Conformities (together with the Legal Manufacturer representative), and other necessary declarations and statements necessary for regulatory activities

- Medical Device technical documentation (MDTF) creation, update and maintenance as per GSK Quality System/Procedures and in the relevant Consumer Healthcare electronic document management system (eDMS) ensuring among others:

• Ownership and coordination with functions of Risk management prior or post CE Marking


• Supervision and approval of MDTF at creation or during update in case of changes (both significant and non-significant. Includes labelling texts and instructions for use for Medical Devices updates)


• Timely periodic reviews as per Quality Management System requirements

- Delivery of regulatory evaluation / strategy and MDTF update in case of non-technical changes (both significant and non-significant). Technical changes are handled by GRA CMC team.

- Regulatory communication with Notified Body, including initial MDTF and input to significant changes submissions, coordination of answers to questions from Notified Body / Competent Authorities / Health Authorities

- Representation of GRA during audits with MDTF or Medical Devices Regulatory activities in scope.

Why you?

Basic Qualifications:

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

• Bachelor’s degree in Life science/Pharmaceutically-related science (Chemistry, Pharmacy, Biochemistry, Biology, Medical Engineering)


• 4 + years’ experience in Regulatory Affairs

Preferred Qualifications:

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

• RAC, Masters or PhD(PharnD/JD QP

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

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