GSK

Director, Global Regulatory Affairs (RNA Vaccines)

Employer
GSK
Location
Rockville, Maryland; Collegeville, Pennsylvania
Salary
Competitive
Posted
October 08 2021
Ref
307538
Organization Type
Pharma
Site Name: USA - Maryland - Rockville, USA - Pennsylvania - Upper Providence Posted Date: Oct 8 2021 Are you interested in a highly-visible US regulatory affairs role that allows you to drive strategy and shape integrated regulatory development across portfolios? If so, this Director, Global Regulatory Affairs (RNA Vaccines) could be an ideal opportunity to explore. This role will focus on the development of therapeutic and mRNA based prophylactic vaccines within GSK. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following… Provide input to/manage regulatory activities in order to obtain Marketing Authorisations for new vaccines as rapidly as possible, with the best possible label, and to maintain these authorisations. Determine from a strategic and scientific perspective the content of regulatory documents submitted to FDA (eg. BLA, sBLA, Q&A, scientific consultations, PSP, INDs, etc.) and ensure that these documents meet high scientific standards and regulatory requirements. Lead multidisciplinary forum, compile/write/review high quality project/product specific regulatory documents to be submitted to FDA (for clinical/labelling, CMC/NC and/or procedural) and ensure that those documents meet regulatory requirements. Provide support in compiling/writing US relevant sections of briefing documents for internal governing bodies and other relevant internal documents (eg Global Regulatory Plan, etc.). Provide US strategic regulatory input for all development stages of the project/product within a given product portfolio to key stakeholders (e.g., provide advertising and promotional expertise to US commercial team). Cover project-specific responsibilities within a given portfolio, and serve as line reviewer for US submissions to ensure adequacy and optimization where possible of US specific aspects Participate in project/product-related discussions and provide strategic, scientific and regulatory input, for FDA 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. Provide input to Vaccines Development Plans in order to optimize the US label and secure proper alignment of CMC/NC and/or clinical/labelling. Assure use of appropriate regulatory procedures to secure the optimum submission strategy and achievement of US commercial promotional goals. Facilitate and deliver the regulatory strategy to support the lifecycle of the asset; accountable for execution for US clinical/labelling, CMC/NC and/or procedural RA aspects. 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 collaborators (within RA team and in multidisciplinary teams) to achieve quality output, accountability and recognition across the organization and towards the FDA. 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. May act as lead or N+1 within the project, being accountable for the overall delivery of project-related activities, in collaboration with the members of the team. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelors degree& 10 plus years in regulatory affairs OR Advanced Degree & 5 plus years Experience in scientific and regulatory 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 NDA/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 Excellent Communication Skills Experience working successfully in a matrix environment Strong leadership skills 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). 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 #careersinvaccines and VxRD* 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.

Similar jobs

Similar jobs