Director, Global Regulatory Affairs
Scientific Degree such as MS, Pharm D, Ph.D. with commensurate combination of scientific degree & experience.
Strong leadership capabilities and ability to think strategically
Significant regulatory experience in development and life-cycle management; experience in oncology preferred.
Demonstrated track record of working in a global team and matrix organization
Demonstrated track record in building trust with key stakeholders and operating with an enterprise approach
Strong written and verbal communications skills
Strong negotiation skills across levels within an organization and with external stakeholders
Strong ability to influence and drive change
Strong ability to manage multiple projects and proactively plan
Significant experience integrating regulatory science with general scientific knowledge and business acumen
Direct experience in the development of medicinal products, health authority interactions and obtaining licenses in different geographic areas.
GlaxoSmithKline (GSK) is a science-led, global healthcare company that researches and develops innovative products. GSK currently employ over 100,000 people globally and has offices in more than 115 countries. The Company has major research centers in the UK, USA, and Spain, Belgium and China and an extensive manufacturing network with 84 sites globally. The Company strategy is focused around growing a diversified global business, delivering more products of value, and simplifying their operating model. Being a responsible business is central to the strategy, and how they deliver success is just as important as what they achieve. In order to ensure they meet society's expectations, the company ensures that their values are embedded into the organisation's culture and decision-making. By investing in these areas the Company will increase growth, reduce risk and improve their long-term financial performance. GSK is a globally renowned company that owns internationally recognized brands and products. They have a healthy pipeline of innovative products and are well positioned to continue their success into the future.
Responsibilities and Accountabilities
- Serve as an empowered Regional or Global Regulatory Lead for the asset/group of assets for the Therapeutic Group(s); key point of contact on the Medicine Development Team and within GRA;
- Provides counsel and interpretation of health authority feedback, guidelines and policy to project team for assigned asset in alignment within global regulatory affairs;
- Participates in the design and interpretation of results from medicines development program;
- Integrate all aspects of strategic & operational regulatory input to asset development in conjunction with clinical, technical, clinical pharmacology, biostatistics, non-clinical, biomarker/pharmacogenomics and diagnostic/device stakeholders as appropriate
- Provides regulatory due diligence into business opportunities as needed;
- Develop the asset specific regional and/or global regulatory strategy, including ownership and accountability as needed;
- Input to Medicine Development Strategy and Commercialization strategy in order to optimise the label and ensure alignment with business objectives;
- Lead preparations and delivery of Health Authority Interactions with asset Medicine Development Team for regional/global Health Authority interactions
- Drive or support efforts to shape the regulatory environment
- Point of contact for Regulatory Agencies for asset (or oversight/support to regional points of contact to authorities)
- Responsible for keeping management team informed of regulatory status of projects and any risks/issues;
- Anticipate and plan for changes in the evolving regulatory environment and policy/regulations; develop and implement risk mitigation strategies as appropriate
- Lead regional and/or global filings with high quality and expedited fashion. Do this in alignment with regulatory, development and commercialization strategy to optimize the value of our medicines to patients, payors and the business. Develop, review and complete submission documents in collaboration with other functional disciplines. Achieve this in a collaborative and trusting relationship with regulators and other external stakeholders.
- Deliver all maintenance related activities for the asset in compliance with GSK policies/procedures and regulations
- Operate with strong global teamwork with the Regulatory Matrix Team and Medicine Development Team
You may apply for this position online by selecting the Apply now button.
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