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Director, Regulatory Affairs, US Classic & Established Products Therapeutic Group

Research Triangle Park, North Carolina; Rockville, Maryland; Philadelphia, Pennsylvania; Collegeville, Pennsylvania
Closing date
May 18, 2022

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Other, Legal/Regulatory Affairs
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Site Name: USA - North Carolina - Research Triangle Park, USA - Maryland - Rockville, USA - Pennsylvania - Philadelphia, USA - Pennsylvania - Upper Providence Posted Date: Feb 8 2022 The Director, Regulatory Affairs, US Classic & Established Products Therapeutic Group leads a small team of Regulatory professionals to ensure the development of appropriate US regulatory strategy(s) for HIV & GSK's Classic and Established Products and their execution for assigned asset(s) and ensuring compliance with FDA regulatory requirements. Our Global Regulatory Affairs organization plays a critical role in enabling delivery of innovative biopharmaceuticals to patients. As an integrated Global Regulatory Affairs team, our regulatory functions drive business-aligned, innovative regulatory strategies related to the discovery, development, registration, commercialization, and lifecycle management of products (pharmaceuticals and vaccines) that maximize the value of the R&D pipeline and our existing product portfolio in markets around the world. We also operate a continuous learning organization that recognizes the importance of proactive efforts to shape the evolving external regulatory environment in order to enable novel regulatory pathways for our portfolio of medicines. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following… Leadership of a team of 4 Regulatory staff Ensuring the regulatory strategy that will deliver the needs of the US Maintain the label for assigned products Partnership regional commercial and medical teams in the US and other teams within Global Regulatory Affairs Providing regulatory leadership for Business Development activities Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor's in an appropriate scientific subject with 5 plus years of experience in all phases of the drug development process in regulatory affairs Experience in all phases of the drug development process in Regulatory Affairs, with emphasis on life-cycle management of marketed products Experience in leading US regulatory strategy development, submission and approval activities Knowledge of licensing requirements in the US Experience of working as part of a multi-functional matrix team Preferred Qualifications: If you have the following characteristics, it would be a plus: Advanced Degree Ideally also a significant external network at least into other pharmaceutical companies and recognized internally and externally as an expert broadly or in specific areas of regulatory affairs Excellent communication skills, ideally in writing and verbally. Proven ability to deliver key communications with clarity, impact and passion. Proven ability to foster strong matrix working. Ability to lead through change Able to implement plans and hold self and team accountable for delivery of short and medium term goals Experience of line management of staff 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. *This is a job description to aide in the job posting, but does not include all job evaluation details. *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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