Site Name: USA - Pennsylvania - Upper Providence, USA - Maryland - Rockville, USA - Massachusetts - Waltham, USA - Pennsylvania - Philadelphia Posted Date: May 3 2022 We have exciting career opportunities in Global Regulatory Affairs for senior level individual strategic contributors to support exciting and innovative research across a variety of specialty therapeutic areas and potentially including Covid-19 therapies. Since the COVID 19 outbreak, 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 GlaxoSmithKline (GSK) Pharmaceutical Research & Development (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 in Collegeville, PA but remote working arrangements may be considered on an individual basis for candidates not local to our Collegeville campus. In this role, you will provide regulatory strategic leadership and support for early and/or late-stage Pharmaceutical R&D portfolio Therapeutic Group, Global Regulatory Affairs Our Global Regulatory Affairs (GRA) Therapeutic Group (part of the Global Regulatory and Quality organisation 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 The Role - Director, Therapeutic Group, Global Regulatory Affairs 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 Authorisations. 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 within Oncology. Prior experience leading health authority interactions; experience leading or supporting major submissions from filing through approval Leadership and strategic thinking capabilities Experience integrating regulatory science with scientific/clinical knowledge Track record of working in a global team and matrix organisation Strong written and verbal communications skills Excellent negotiation skills across levels within an organisation and with external stakeholders Experience managing multiple projects and proactively planning Experience in working with strategic partners/cross company collaborations Domestic and international travel ~10% Commute to work location with domestic relocation available for those meeting requirements 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 partnering with business development in due diligence efforts 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, talent and technology 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. As a science-led healthcare company on a mission to get ahead of disease together, we believe that supporting vaccination against COVID-19 is the single best thing we can do in the US to ensure the health and safety of our employees, complementary workers, workplaces, customers, consumers, communities, and the patients we serve. GSK has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. The only exceptions to this requirement are employees who are approved for an accommodation for religious, medical or disability-related reasons. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.