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Senior Director, Global Regulatory Affairs

United States
Closing date
Feb 6, 2022

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Other, Legal/Regulatory Affairs
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Site Name: USA - Pennsylvania - Upper Providence, Home Worker - USA Posted Date: Jan 28 2022 *Potential Remote Opportunity Are you passionate about Specialty Care Products? Are you a Regulatory Affairs professional looking for a new and exciting opportunity in a growing organization? Are you interested in leading and managing people? If so this Senior Director of Global Regulatory Affairs role could be a great fit for you! We are seeking candidates with a combination of strong regulatory affairs and therapeutic area experience across a range of diseases. The ideal candidate should also be a strong leader of people and matrix teams intended to join GSK Global Regulatory affairs as Senior Director to work on products in cutting edge areas of science. This role will provide YOU the opportunity to lead key activities and possibly manage regulatory staff to progress YOUR career, these responsibilities include some of the following: Serve as an empowered Global Regulatory Lead and/or Regional Lead for assigned assets Strategically partner with the development and commercialization teams and work closely with the broader regulatory matrix team to conceive and deliver innovative regulatory strategies for assigned assets 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, etc. Lead preparations and delivery of Health Authority interactions and marketing authorizations with the cross functional development and regulatory team Proactively counsel and interpret health authority feedback, regulatory precedent, guidelines and policy to drive the product strategy, as well as driving or supporting efforts to shape the regulatory environment. Potentially lead/line manage other regulatory staff. Basic Qualifications: We are looking for professionals with these required skills to achieve our goals (must-have): Bachelors Degree 5 plus years of regulatory experience in drug development and life-cycle management Prior experience leading health authority interactions and major submissions from filing through approval. Experience across multiple therapeutic areas Global regulatory experience Preferred Qualifications: If you have the following characteristics, it would be a plus: Master's Degree or PhD (or equivalent) Experience in line management Experience in companion diagnostic and device Excellent negotiation skills across levels within an organization and with external stakeholders Ability to manage multiple projects and proactively plan Experience in working with strategic partners/cross company collaborations Experience in partnering with business development in due diligence efforts Why GSK? Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities: Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigour and risk Managing individual and team performance. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Implementing change initiatives and leading change. Sustaining energy and well-being, building resilience in teams. Continuously looking for opportunities to learn, build skills and share learning both internally and externally. Developing people and building a talent pipeline. Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation. Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally. Budgeting and forecasting, commercial and financial acumen. *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.
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