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Senior Global Regulatory Lead, Shingrix

Rockville, Maryland
Closing date
Jan 21, 2022

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Pharmaceutical, Regulatory Affairs
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Site Name: USA - Maryland - Rockville, Belgium-Wavre Posted Date: Oct 20 2021 Job purpose: The Senior Global Regulatory Lead (GRL) Shingrix will provide strong leadership and management to Regulatory staff in charge of the Global Regulatory strategy, in order to develop and oversee the Global Regulatory Plans (GRP) linked to the programs and assets under the accountability of that respective Research Development Centers (RDC) - based in the USA, Belgium and Italy. This will require full strategic integration and alignment with other RDC functions, including the Discovery Project Units (DPU), Vaccine Development Teams (VDTs) and Vaccine Commercialization Teams (VCTs), from the early phase through Life Cycle Management (LCM). Key responsibilities: This role is broad and very strategic and has a fundamental impact on the product(s)/project(s). Leadership & Team management: Senior Team leader driving capabilities (talent and resources), performances and continuous improvement in line with GSK's expectations. Manage and lead a team that will include multiple GRLs across a grouping of projects (portfolio) who in term will have a team of clinical and technical regulatory experts specific to that subgrouping of projects; Establish career development plans with individuals and propose opportunities accordingly, to promote retention and grow group expertise. Provide input, guidance and support for development of talent in the GRA and the RDC; Drive interactions with other functions within GRA (such as Regulatory Operations, Regional Heads, CMC or ClinRA excellence) and with the DPUs, VDTs and/or VCTs: Lead GRA's efforts in enabling collaboration with all functions in DPUs, VDTs and/or VCTs, including, e.g.: taking on the leadership of a VCT stream; Ensure full partnership with the DPL, VDL and/or VCL as well as the Head GRA of RDC for identification of priorities, objectives and performance evaluation of all team members as well as associated resources allocation; Ensure in collaboration with the relevant RA functions, as appropriate, the resources to ensure execute the agreed RA plan; Act as, or manage, the single point of Regulatory contact for DPUs, VDTs and/or VCT as appropriate, plus other internal project related teams (e.g. LTT, SRT etc.). Regulatory: Accountable for the development and implementation of the regulatory strategy for the projects under your accountability, including sign-off of all regulatory submissions; Accountable for compliance with regulatory obligations linked to the programs/assets under your accountability; Accountable for the Global Regulatory Plans (GRP) and associated Key message summaries for the assets/products under your accountability; Oversight and ensure consistency of GRA input into Vaccines Development Plans in order to optimize the label and secure proper alignment of technical, clinical and non-clinical aspects and optimized regulatory procedures to secure the optimum submission; Partner with RA Regions to ensure efficient interactions with the regulatory authorities to achieve on-time approvals of GSK Vaccines submissions for the asset(s); Ensure identification and communication of product related items and issues required to maintain the regulatory status of approved products in all markets. Direct and supervise submission of required documentation for scheduled renewals and as-needed submissions based on new manufacturing, safety or clinical data; Provide strategic RA inputs, updating on RA plans/activities and discussing priorities with DPT, VDT and VCTs, as needed; Member of the corresponding DPT, VDT and/or VCT; Member of the Global Regulatory Affairs RDC Leadership Team. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Advanced Scientific Degree in General Science or Life Science At least 10+ years of experience in managing Regulatory projects and engaging directly with regulatory agencies and personnel; At least 5+ years of significant supervisory/management experience in a business-driven, globally regulated pharmaceutical environment including experience in remote management and matrix environment; Proven in depth knowledge is required and covers scientific as well as regulatory expertise: Scientific includes medicine, biology, infectious diseases, immunology, clinical trials management, statistics, epidemiology, technical and non-clinical. Regulatory includes extensive knowledge of cGMP, ICH, QA/Q and product development principles; guidelines, legislation, registration procedures including labelling, regulatory authorities across the different regions of the world; Direct experience in the development of medicinal products and obtaining licenses in different geographical areas; Proven ability to develop Company's regulatory positioning, and write strategic documents targeting internal or external key audiences; Proven ability to manage challenging situation with a constructive mindset and willingness to resolve or taking clear decisions; Fluency in English both written and spoken. Preferred Qualifications: If you have the following characteristics, it would be a plus: Ph.D. or M.D in Pharmacy, Chemistry, Biology or Medicine Strategic thinking Proactive leadership to identify issues and mitigation strategies, maximize opportunities, with proven ability to develop collaborative relationships and have high impact and influence People management (direct and indirect) Influencing and presentation skills Recognized communication skills, both spoken and written Problem-solving Enterprise thinking Cultural awareness Fluency in French and/or Italian. *LI 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, rigor and risk, governance and control, managing ambiguity and paradox. Managing individual performance. Creating a performance culture and driving results, prioritization, execution, delivering performance. Setting strategic direction and leading on-going organizational transformation. Building a resilient organization. Building strong relationships and collaboration in service of common goals, engaging the organization and building trusted external networks for mutual benefit. Managing P&L and capital allocation. 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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