Manager Oncology GRA

Company: GlaxoSmithKline
Location: Rockville
Posted on: August 4, 2022

Job Description:

Site Name: USA - Pennsylvania - Upper Providence, USA - Maryland - Rockville, USA - Massachusetts - Waltham Posted Date: May 18 2022 We have exciting career opportunities in Global Regulatory Affairs for Manager 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. In this role, you will provide regulatory strategic leadership and support for early and/or late-stage Pharmaceutical R&D portfolio. 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 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. Purpose Ensure the development of appropriate global and/or regional regulatory strategy(s) and their execution for assigned asset(s) consistent with Medicines Development Strategy /Integrated Asset plan to ensure the development program meets the needs of the key markets identified and the Medicines Profile. This goal has to be achieved while ensuring compliance with both internal GSK process / policy and with appropriate regulatory requirements to deliver the best possible labeling to meet the Medicine Profile, commensurate with the available data Accountable to GRL and Global Regulatory TA Head for development of appropriate regional regulatory strategy(s) and for delivery according to plans. In conducting role, planning will be on a multiple year horizon, with delivery requiring extensive matrix working within GSK to VP level and representing GSK with at least the local regulatory agency. Work with the Early/Medicine Development Team (EDT/MDT) or GRL, to ensure a robust regulatory strategy is in place to support the development program to meet the needs of the key markets identified in the Integrated Asset plan and the Medicine Profile. Work closely with local / regional commercial team to secure best possible labeling commensurate with the available data. Lead interactions with local / regional regulatory authorities. In performing the role, the job holder will be responsible for: Proactively developing regulatory strategy that will deliver the needs of the local region(s), taking in to account the needs of other regions globally. Implementation of the regional strategy(s) in support of the project globally Lead regulatory interactions and the review processes in local region Ensuring appropriate interaction with global/regional counterparts and commercial teams in local region Ensuring compliance with global/ regional requirements at all stages of product life Ideally assess precedent, regulatory intelligence and competitive environment from a regulatory perspective for the region and the impact this will have on the regulatory strategy for an asset Good communication skills, especially in writing. Capable of delivering key communications with clarity, impact, and passion Ideally good listening and comprehension skills; proactive in identifying potential issues and escalating them accordingly Ability to foster strong matrix working. Facilitates dialogue between team and matrix members to contribute their ideas. Capable of developing and recommending strategies for change. Capable of identifying project or team issues in advance and seeking necessary help and support to resolve. Ability to derive creative solutions to regulatory problems, while balancing the expectations of Agencies and ensuring compliance with regulation in all regions. Recognizes potential long-term issues for projects. Ability to make sound decisions and in doing so, the job holder will use a range of sources and weight benefits and risks before making important decisions. Shows a constant focus on improving performance and excellence in all tasks. Challenges and questions ways of working to seek improved process. Seeks to raise levels of performance by establishing or improving process Developing personal networks, within GSK and capable of using them to secure appropriate support and outcome for a project. Why You Basic Qualifications: Bachelor's degree or preferably PhD in biological or healthcare science 5 years' Experience of all phases of the drug development process in regulatory affairs preferred 5 years' experience of leading regional development, submission and approval activities in local region(s) 5 years' Experience with clinical trial and licensing requirements in all major countries in the region and ideally knowledge of other key Agency processes globally. Preferred Qualifications: Knowledge of relevant therapy area, and ability to further develop necessary specialist knowledge for the product or area of medicine 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 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. *LI-GSK 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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Keywords: GlaxoSmithKline, Rockville , Manager Oncology GRA, Healthcare , Rockville, Maryland