Regulatory Affairs Executive/Regulatory Affairs at GlaxoSmithKline

Job Purpose

• As a Regulatory Affairs Executive you will ensure products within scope can be placed on the market with optimal yet compliant claims, advertising, and promotion in line with commercial plans. You will ensure products are maintained and meet internal and external compliance requirements. You will also be a productive part of defined Cx local regulatory team, including being a proactive partner to other stakeholders, e.g., marketing/sales within local commercial business, supply chain (GMS) and quality etc.

Essential Job Responsibilities:

• Manage preparation of regulatory documents, dossiers and applications to enable new products to be launched and maintained in market, with the correct alignment and compliance to regulations, proactively seeking innovative and rapid path to market.
• Analyse regulatory issues and communicate with key stakeholders. Work together to help develop plans to mitigate, so that we can deliver science that is robust and aligned with business needs.
• Actively contribute to the activity of a high performing local teams, including looking for ways to improve the performance.
• Build relationships with key stakeholders and represent GSK in an appropriate manner according to company values, in order to present GSK CH policies and strategies.
• Manage compliance within defined portfolio/activity streams in line with GSK CH expectations -  support key processes and ways of working (e.g., in relation to GSK CMC, quality, product labeling requirements as well as local MoH regulations).
• Work together with other functions (e.g., marketing, supply chain) to deliver NPD and value engineering projects.
• Support the development of the strongest claims/advertising and promotion possible within the regulations, ensuring risks are appropriately addressed and communicated.

Why you?

Basic Qualifications:

• BPharm or BSc degree
• Relevant 2 year’s experience in Regulatory Affairs

Preferred Qualifications:

• Regulatory clearance is a pre-requisite of any product marketing
• Compliance to regulatory requirements and management of health authorities is essential to Corporate compliance
• Ability to effectively communicate and negotiate in relation to technical information and regulations is key.