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Director, US Regional Expert, Regulatory Affairs Operations

Employer
GSK
Location
Rockville, MD
Salary
Competitive
Closing date
Dec 9, 2021

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Site Name: USA - Maryland - Rockville Posted Date: Dec 1 2021 We are looking for a talented Director with extensive global regulatory affairs knowledge/experience and excellent interpersonal skills to join our Vaccines Global Regulatory Affairs team in Rockville, MD. You will be empowered to develop appropriate global/regional regulatory strategy(s) and ensure their execution for assigned vaccine asset(s). With your extensive regulatory expertise and strong communication/negotiation skills, you will provide regulatory strategic leadership and support for early, late stage, and life cycle management of the assign vaccines portfolio. Responsibilities include: Provide science-based, strategic input and management of regulatory activities; Function in a leadership capacity across a matrix team to develop and submit regulatory documents to the health authorities (e.g. INDs and their amendments, CTA's, formal meetings and scientific consultations/advice, PSPs and PIPs, etc.) and ensuring that these activities meet high scientific standards and regulatory requirements. Provide support in compiling/writing regulatory-related sections of briefing documents for internal governing bodies and other relevant internal documents (eg Global Regulatory Plan, etc.). Participate in project/product-related discussions and provide strategic, scientific and regulatory input for FDA and ex-US specific aspects of given project topline and in depth on clinical/labeling, CMC/NC, advertising and promotion and/or procedural aspects. Serve as the point of contact for FDA for specific products and development programs. Ensure professional and collegial relationship, applying best practices for each program assigned. Assure use of appropriate regulatory procedures to secure the optimum submission strategy and achievement of US commercial promotional goals. Stay current with changes in regulatory guidelines and rules, understand and communicate their impact on regulatory strategy for the particular asset(s); advise project teams on how best to address changes. Develop and motivate RA team members and collaborators to achieve quality output, accountability and recognition across the organization. Ensure planning and proper organization of US activities in line with the overall project plan and RA milestones; Raising risks (such as gaps in resource or project related) for resolution within global teams. Support the Global Regulatory Lead in providing robust regulatory advice and plans to the various project teams and advisory bodies to ensure that the business needs are in compliance with regulations and/or regulatory advice received from the agencies. Lead Global Regulatory functional communications strategy, maintaining flow of information via email, presentations, website, town halls, and other information sharing. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor's degree and 10 plus years' experience in regulatory affairs; Scientific and regulatory experience in in all stages of product development. Experience in clinical regulatory affairs as well as CMC regulatory affairs for pre-licensed and licensed biologic product or vaccine Knowledge in IND and BLA regulations and US regulations pertinent to product development and licensure Knowledge of scientific basis for clinical development, endpoints, and product CMC Experience as liaison with US FDA Preferred Qualifications: If you have the following characteristics, it would be a plus: Experience at a large pharmaceutical/vaccines company Experience working successfully in a matrix environment Strong leadership skills Experience leading health authority interactions Experience leading or supporting major submissions from filing through approval A preferred candidate would show strengths in the following areas: Strategic Leadership - Experience in providing strategic advice on integrated regulatory development plans and life cycle management, preferably for the US. Providing US-focused input into regulatory strategy, evaluating potential impact on overall project/product strategy. Leveraging internal and external regulatory and scientific networks to problem solve. Providing input into corporate regulatory positioning including US key considerations early in the product development. Writing/critically reviewing, while ensuring rigorous scientific content/quality/compliance, key documents targeting internal or external key audiences, including but not limited to initial IND and related amendments, annual reports, status reports on post marketing requirements/commitments related to clinical safety, clinical efficacy, or clinical pharmacology, briefing documents, key meeting summaries, and BLA modules. People & Program Management - Identifying and escalating regulatory or programmatic issues while proposing mitigations strategies and solutions/problem solving. Developing plans and timelines for complex projects and collaborating with other departments and teams in the delivery of outputs in a timely manner. Forming collaborative relationships and having high impact and influence on multicultural, diverse, and/or international teams. Ensuring that a corporate or departmental regulatory voice is clearly articulated and heard consistently and concisely in various cross functional teams. Enterprise thinking - Understand the constraints and drivers of other functions and the potential impact on regulatory affairs World-wide, including how regulatory affairs may facilitate in achieving the overall corporate goal. Proactive leadership - Identify issues and maximize opportunities. Quickly assimilate facts and data and develop an understanding of complex matters with the ability to translate this understanding to internal stakeholders (regulatory and non-regulatory experts). *LI-GSK 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. 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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