QUALIFICATIONS/SKILLS:

• Master’s or PhD in Pharmacy, Bio Medical/Life science/Pharmaceutically-related science (Chemistry, Biochemistry, (Medical) Biology, Medical Engineering).
• 3–5 years of experience in regulatory affairs within the pharmaceutical industry.
• Experience in maintenance of licences and registration of new products.
• Strong verbal and written communication skills in English and Dutch.
• Proven ability to manage complex assignments and meet deadlines.
• Analytical mindset with attention to detail and problem-solving skills.
• Experience with risk mitigation and process improvement.
• Experience with regulatory compliance databases and systems.
• Stakeholder management.

IN THIS ROLE, YOU’LL ENSURE OUR PRODUCTS MEET REGULATORY REQUIREMENTS AND ARE REGISTERED AND MAINTAINED THROUGHOUT THEIR LIFECYCLE. YOU’LL COLLABORATE WITH CROSS-FUNCTIONAL TEAMS, INCLUDING MARKETING, MEDICAL, MARKET ACCESS, SUPPLY CHAIN, QUALITY, ETC, TO DELIVER BUSINESS OBJECTIVES. WE VALUE CANDIDATES WHO ARE DETAIL-ORIENTED, PROACTIVE, AND PASSIONATE ABOUT DRIVING COMPLIANCE AND INNOVATION.KEY RESPONSIBILITIES:

• Lead preparation of new regulatory documents, dossiers and applications to enable new products to be launched and maintained in market, with optimized registered Product Information and the correct alignment and compliance to regulations.
• Analyse regulatory issues and communicate effectively with key stakeholders, including global colleagues. Lead development of strategies and mitigation plans that are robust and aligned with business needs.
• Actively contribute to high performing teams, including looking for ways to improve performance. May lead cross-functional teams and regulatory professionals in the context of a project etc.
• Build relationships with key stakeholders and represent GSK in a responsible manner according to company values, in order to communicate GSK policies and strategies and negotiate outcomes.
• Manage compliance within defined portfolio/activity streams in line with GSK expectations - support key processes and ways of working (eg, in relation to GSK CMC, quality, product labeling requirements as well as CBG/MEB regulations). Propose solutions to identified issues and implement.
• Work together with Pack Management Executives to coordinate and approve final artwork and ensure packaging components are printed/produced in line with regulations, GSK expectations and commercial plans.
• Collaboratively working together with other functions (eg. medical, marketing, supply chain, QA) to help implement aRMMS, discontinuations and license withdrawals, to deliver company objectives and contribute to DHPC and product incidents/recalls.
• Proactively identify potential regulatory risks and manage impact of regulatory changes within defined scope of responsibility on the business.
• Maintain required high level of product knowledge within defined portfolio, regulatory compliance databases, systems and processes.