10+ years significant experience in regulatory affairs, or appropriate relevant experience
• Experience in managing teams and leading in a matrix organization. Experience with global teams preferred.
• Knowledge and expertise in CMC, NC, Clinical, labeling and procedural aspects (at minimum two of these areas)
• Deep experience with US regulatory environment
• Prior experience with biologics or vaccines is required.
PhD/MD in Pharmacy, Chemistry, Biology, Medicine, or similar discipline.
Experience at a large pharmaceutical/vaccines company
Experience with global teams preferred.
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 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 mitigation 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. Ensure that a corporate or departmental regulatory voice is clearly articulated and heard in consistently and concisely in various cross functional teams. Developing, mentoring, and coaching junior staff.
• 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.
GlaxoSmithKline (GSK) is one of the world's leading research-based pharmaceutical companies with a broad range of innovative products in three primary areas: Pharmaceuticals, Vaccines and Consumer Healthcare. GSK vaccines are included in immunization campaigns in 182 countries with 860 million vaccine doses distributed to 170 countries in 2013, of which 80% were to developing countries. Our Vaccines R&D work focuses on discovering and developing vaccines to help protect people against a broad range of diseases and conditions across all age groups. We have a pipeline of 14 candidate vaccines in early, mid and late stage development against a range of diseases.
North America Regulatory Affairs (NARA) is a dynamic and growing part of GSK Vaccines' Global Regulatory Affairs Organization. The Rockville, MD-based group of regulatory experts focuses on GSK's U.S.-licensed and developing-vaccine pipeline and provides advice on U.S. regulatory strategy for cutting-edge, novel vaccine technology while also delivering on post-marketing reporting requirements, regulatory filings in support of new applications, and liaising with the U.S. FDA and global product leads. The group's leadership team members have diverse scientific backgrounds in virology, pharmacology, biochemistry, chemistry, and molecular biology, with decades of combined experience in drug development and vaccines.
As a US Group Lead, Project Portfolio*, within North America Regulatory Affairs, you will be responsible for regulatory submissions, interactions, and strategy related to products within the US. The role provides US-focused strategic advice and executes on deliverables for US submissions and FDA interactions. The function has reporting requirements to the VP and Head of NARA and includes people and project/portfolio management benchmarked to key performance indicators aligned with the department and global objectives. Role will be part of the NARA leadership team (NARA LT) and share responsibility for overall US regulatory strategy and operations.
As a US Group Lead, Project Portfolio*, Global Regulatory Affairs you will have the following responsibilities within a specific GRA project/portfolio within GSK Vaccines:
• Cross portfolio aligned regulatory strategy to assure timely approvals for all US submissions.
• Facilitate integration of US-based individuals within portfolio group and integration of US-specific regulatory aspects into projects in general within the portfolio
• Ensure US-specific regulatory learnings are shared with the rest of the team, in line with culture of coaching
• Managerial responsibilities for US-based individuals within a specific GRA project/portfolio, consisting of resources overview and optimization at US GRA level, advice for US specific activities/processes, ensure appropriate training of US-based staff, and issue escalation:
• Management of US based staff within Portfolio
• Resources overview and optimisation of work distribution within Product/Project teams in agreement with GRL/RA RDC Head/NARA Head
• Cross portfolio resources support as appropriate
• Provide advice on US-specific activities and ways of working, processes as mentor or coach; in this role, provide support, as needed, for meetings/teleconferences with US regulatory agency, if deemed appropriate in discussion with US-based individual in charge of the project and the respective GRL or RDC personnel.
• Escalate issues as appropriate
• Ensure the training of US-based personnel, and ensure completeness of training curriculum, in compliance with CIA
• Project-specific responsibilities:
• May be involved in review of US submissions, upon request of the Global Regulatory Lead (GRL) or NARA Head, to ensure adequacy/optimization of US-specific aspects within a submission.
• In their direct line to Head North America, the job holder will ensure:
• That regional strategic input is provided into RA project strategy and escalation as appropriate - i.e. ensure alignment and sharing of information/strategy across region and central GRA
• Attendance to NARA staff meeting
• Ensure alignment and adequate support of US Reg Ops
• Quality and process improvement within US
You may apply for this position online by selecting the Apply now button.
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