Job Description

Job Purpose

• Development (regional input) and implementation of business-focused, high-quality, timely regulatory strategy to support post-approval activities;
• Maintenance of authorised licenses in compliance with local regulations, active portfolio management and delivery of lifecycle innovation activities in alignment with regional commercial strategies;
• Collaboration with Regional Portfolio Optimisation team to support Local Operating Company Regulatory Affairs (LOC RA) to achieve the cross-regional/functional alignment and regional objectives;
• The role manages across the portfolio (including ViiV) and leads cross-business initiatives within Region as applicable.

Primary responsibilities

• Collaborate with Central RA and LOC RA at early stages of development of post-approval regulatory strategies to advise on options for effective planning of these strategies in Region (e.g. prioritisation of submissions across Region based on regulatory requirements and commercial opportunities)
• Act as Regional liaison in interactions between Central RA and LOC RA to support successful implementation of post-approval regulatory strategies, including collaboration with global oversight teams to ensure regional business priorities are incorporated into the global regulatory strategies
• Anticipate and escalate any risks / issues related to post-approval activities in Region. Engage in timely manner with Central RA and LOC RA to support risk mitigation and escalation of issues
• Work with Regional teams to ensure alignment with the commercial objectives and contribute to the decision-making process according with specific requirements for key post-approval filings / markets, anticipates and escalates any risks / issues related to supply disruption that could affect the deliverable targets
• Represent Regional Portfolio Optimisation function in global forums and cross-functional collaboration to advocate regional position and address regional-specific issues
• Maintain oversight and provide guidance on all post-approval activities such as license re-activation, license renewal, license cancellation, license divestment, variations, response to questions and post-approval commitments
• Understand, interpret, and advise on local regulatory requirements and their implementation. Liaise with Subject Matter Experts to raise awareness for impact evaluation of emerging and/or changing regulations, share across Region as well as collaborate in the monitoring of regulatory environment, share best practices and experiences. Identify possible risks and develop regional mitigation strategies at early stage based on available experience and expertise
• Understand, interpret and advise on processes & guidelines and their implementation / use at local level. Provide regional view & input on development / revision of global and regional processes. Identify possible opportunities of process improvement / simplification, harmonise suggestions across regions. Develop the appropriate solutions for unmet needs or region-specific requirements and discusses them with global / regional teams

Why you?

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

• Bachelor Degree in Life Sciences / Pharmacy
• 10 years of experience in pharma industry
• 8 years of experience in Regulatory Affairs (local / regional / central) with at least 3 years of experience in a senior role (e.g. manager / team leader)
• Experience of working effectively in a matrix across functions
• Experience of project management and leading projects. Strong management and project leadership skills, ability to provide operational oversight and support to project teams in strategic decisions and guide them through diverse and conflicting regulatory requirements
• Experience of working in a CMC (Chemistry, Manufacturing, Control) team and/or on CMC related projects with a proven track record

Why GSK?

To learn more about Singapore GSK and our people, please click on this link:

*LI-GSK

GSK is a global biopharma company with a special purpose \xe2\x80\x93 to unite science, technology and talent to get ahead of disease together \xe2\x80\x93 so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns \xe2\x80\x93 as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it\xe2\x80\x99s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We\xe2\x80\x99re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

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