Purpose
- Development (regional input) and implementation of business-focused, high-quality, timely regulatory strategy to support new product introductions of new pipeline and established products, line extensions, new indications for centrally supported products and where applicable for non-centrally supported products across region.
- Leading the pipeline initiative to develop regional strategies in alignment with Regional Commercial strategies. Prioritization of portfolio strategy across the Region based on commercial expectations and priorities, aimed to achieve an optimal launch sequence of the portfolio for the whole region.
- Working in close collaboration with regional functional leads and GRLs to ensure fastest patient access to GSK innovative products and to support business development opportunities.
- Identifying and analysing all potential opportunities for Innovation in Regulatory Strategy by challenging status quo to increase ambition for patients whilst always doing the right thing.
- Ensuring timely delivery of the AiR (Acceleration in Regions) project regulatory milestones and continuous improvement of the project tool and processes in alignment with organizational and operational changes.
Key Responsibilities
1. Collaborates with GRA, Regional Regulatory Leads and Local Operating Company Regulatory Affairs (LOC RA) at early stages of development and alignment of Regional Regulatory Strategy to advise on options for effective submission planning (e.g. simultaneous submissions in priority markets, filing groups).
2. Works with Regional stakeholders providing regulatory input into regional strategy building; fostering total alignment with regional team on emerging business opportunities.
3. Acts as the regional liaison in interactions between regional commercial, medical, quality, GRL and LOC RA to:
- Contribute to development and implementation of regional regulatory strategies to support successful launch excellence, including collaboration with GRLs on the early settings of the strategy to utilize innovative regulatory strategies (as like reliance mechanisms etc), following up with the global regulatory and development milestones to ensure alignment with business priorities and embed specific regulatory needs (such as GMP inspections, clinical trials etc).
- Ensure that LOC regulatory input for Portfolio Strategy is provided on a timely basis and ensure regional business priorities are incorporated into the global regulatory strategies; work with the LOCs to establish planning including priority and resource for submissions filing.
- Support and monitors timely execution of regulatory submission plans, timely responses to questions to achieve launch excellence in collaboration with GRA and LOCs.
- Active participation in submission meetings e.g. pre-CCM, CCM, forums, RMTs, etc to ensure oneGRA voice.
4. Anticipates and escalates any risks / issues related to Portfolio Strategy activities in the Region. Engages proactively with GRA and LOC RA to support risk mitigation and escalation of issues. Works with the regional franchise teams and Regional NPI board to ensure alignment with the commercial objectives and contribute to the decision-making process according with specific requirements for key products / markets filings, anticipates and escalates any risks / issues related to optimal launch sequence that could affect the deliverable targets.
5. Represents Regional Regulatory function & contribute to portfolio/asset specific knowledge sharing forums.
6. Understands, interprets, and advises on local regulatory requirements and their implementation. Liaises with Regulatory Intelligence team & Subject Matter Experts to raise awareness for impact evaluation of emerging and/or changing regulations, share across the region as well as to collaborate in the monitoring of regulatory environment, share best practices and experiences. Identifies possible risks & opportunities and develops regional strategies at early stage based on available experience and expertise.
7. Manages and follows-up on country-related issues (issues not just restricted to one product team responsibilities, e.g. Missing MSRs, Delays in Submissions, issues highlighted by GRL regarding responsiveness of countries).
8. Collaborates with cross-functional teams to advocate regional position and address regional-specific issues.
9. Acts as advisor in business development opportunities providing Regulatory input at earliest stages of the deals and supporting Due Diligence.
10. Builds the capacity and capabilities within local regulatory teams who are participating in or leading innovation projects:
- Contributes to the development and implementation of regulatory processes and procedures and ensures they remain fully compliant across all relevant regulations and operational & organizational changes,
- Ensures that relevant and timely information of use to local regulatory teams widely available, including handbooks, trainings, updates on asset specific global milestones etc,
- Ensures teams access to relevant, timely and accessible information and resources through workplace, newsletters, meetings etc.
Knowledge, Skills and Experience
- Min degree in life sciences, pharmacy or medicine
- Min 8 years of experience in regulatory affairs and managerial role in multinational companies.
- Min 5 years of experience in matrix management and working in multi-cultural team
Knowledge of the policies, key personnel, and regulatory climate in the area. - Advanced knowledge of drug development process, and regulations and practices affecting the pharmaceutical industry.
- Proven track record of effective collaboration with the regulatory agencies and a history of success in gaining product approvals and defending established products.
- Ability to read, analyse and interpret complex regulatory documents.
- With enterprise mindset, insightful and forward thinking, ability to recognize, anticipate and discuss potential regulatory challenges with teams.
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.
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