Site Name: USA - Pennsylvania - Philadelphia, USA - Connecticut - Hartford, USA - Delaware - Dover , USA - Maryland - Rockville, USA - Massachusetts - Waltham, USA - New Jersey - Trenton Posted Date: May 10 2022 We have exciting career opportunities in Global Regulatory Affairs for director level individual strategic contributors to support exciting and innovative research across the Oncology therapies. We have been actively exploring ways to help, with our science and expertise, alongside protecting the health and wellbeing of our people and managing our global supply chains to support patients and consumers who depend on our products. This represents an exciting opportunity to be part of GSK Pharma R&D, who is committed to innovative scientific research and discovery to help people do more, feel better, live longer. Ideally, the role will be located on East Coast, but remote working arrangements may be considered for appropriate US candidates. In this role, you will provide regulatory strategic leadership and support for early and/or late stage Pharmaceutical R&D portfolio. Job purpose: Our Global Regulatory Affairs (GRA) Therapeutic Group (part of the Global Regulatory and Quality organization in Pharmaceutical R&D) develops global regulatory strategies to deliver our innovative portfolio. We are strategic partners with Pharmaceutical R&D and Commercial in delivering and maintaining our product pipeline, whilst complying with Health Authority regulations. We share learnings and best practices to foster continuous improvement. We strive to shape the evolving regulatory environment and influence policies/guidelines in areas that are key priorities for GSK. We operate by fostering strong global teamwork and building trusting relationships with internal and external partners, including Regulatory Agencies. We use our leadership, strategic thinking, smart risk-taking skills, global regulatory acumen, analytical ability, communication and influencing skills to advise our internal partners and negotiate with external stakeholders. We believe in life-long learning and developing our people. We take ownership of our development, as driven by on-the-job experiences, interactions with people, formal instruction and access to learning resources, with support from our leaders. Your responsibilities: The Director, GRA serves as an empowered Global Regulatory Lead and/or Regional Lead for assigned assets. This role serves as a key strategic partner with the Pharmaceutical R&D and Commercial teams and works closely with the broader Regulatory Matrix Team to conceive and deliver innovative regulatory strategies for assigned assets. The Director must be able to integrate aspects of strategic and operational Regulatory Affairs into asset development, collaborating with the cross functional team including Clinical Research, Biostatistics, Nonclinical, CMC, Diagnostics/Device, Commercial, etc. This role is responsible for leading preparations and delivery of Health Authority interactions, Clinical Trial Applications and Marketing Authorizations. In addition, they must proactively counsel teams, and interpret health authority feedback, regulatory precedent, guidelines and policy to drive the medicine strategy, as well as driving or supporting efforts to shape the regulatory environment. Why You? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelors or advanced degree in appropriate scientific discipline Minimum 5+ years of global regulatory experience in drug development and life-cycle management. Prior experience leading health authority interactions; experience leading or supporting major submissions from filing through approval Demonstrated leadership capabilities and ability to think strategically Demonstrated ability to integrate regulatory science with scientific/clinical knowledge Demonstrated track record of working in a global team and matrix organization Demonstrated negotiation skills across levels within an organization and with external stakeholders Experience in managing multiple projects and proactively plan Preferred Qualifications: If you have the following characteristics, it would be a plus: Master's Degree or PhD Experience of all phases of the drug development process in Regulatory Affairs Experience in working with strategic partners/cross company collaborations Experience in partnering with business development in due diligence efforts *LI-GSK Why GSK At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Health, strengthening our leadership, and transforming our commercial execution. Now, we're making the biggest changes we've made to our business in over 20 years. We're on track to separate and create two new companies in 2022: New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands. With new ambition comes new purpose. For New GSK, this is to unite science, technology and talent to get ahead of disease together - all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive. Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that is ambitious for patients - so we deliver what matters better and faster; accountable for impact - with clear ownership of goals and support to succeed; and where we do the right thing. So, if you're ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead Together. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. At GSK, the health and safety of our employees are of paramount importance. 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