Regulatory Lead

Key Responsibilities:

• Develop best regulatory strategies: continuous analysis of risks and opportunities for new assets requires close follow-up of the internal and external trends and strategic planning from early development through launch.
• Planning and execution of post-approval submissions (renewals, technical variations, new indication, label updates) and conducting effective cross-functional interactions to preserve business continuity.
• Ensure timely regulatory submissions and approvals of new Marketing Authorisation applications & GMP dossiers.
• Lead GMP-related tasks, including inspections, which require close follow-up with internal and external stakeholders.
• Follow up on developments and changes in the local & global regulations and analyze the potential impact on the registrations.
• Interaction with Agency members and external stakeholders.
• Act as a key regulatory stakeholder at brand task force groups (contains multiple functions) to provide input/advice.
• Lead strong relationships with internal and external stakeholders.
• Ensure the organization’s regulatory activities are conducted accurately, ethically, and according to relevant regulations, laws, and standards.

Why you?

Basic Qualifications

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

• Bachelor’s degree in related fields (such as Faculty of Pharmacy, Chemical Engineering, Chemistry, etc.)
• Have minimum 5 years of experience in the regulatory field
• Have a good command of written and spoken English
• Strong command of communication and presentation skills
• Good knowledge of MS Office tools
• Strong planning, follow-up, reporting and analytical skills to achieve accurate and timely results,
• Work precisely according to procedures, rules and regulations

Job Posting End Date:

2 April 2025

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.

Contact information:

You may apply for this position online by selecting the Apply now button.

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