Regulatory Affairs Director, US Regional Expert
- Bachelors degree in chemistry, biology, biochemistry or similarly applicable discipline.
- 10+ years significant experience in regulatory affairs, or appropriate relevant experience in scientific function in vaccine industry combined with at least 4 years direct RA experience ((or advanced degree and 10+ years experience).
- Requires scientific and regulatory knowledge pertinent to all stages of product development;
- Direct experience in clinical regulatory affairs as well as CMC regulatory affairs for licensed biologic product or vaccine is essential.
- Operational knowledge of IND and NDA/BLA regulations and other relevant US regulations pertinent to product development and licensure,
- Understanding of scientific basis for clinical development, endpoints, and product CMC is critical to role.
- Direct experience as liaison with US FDA
- Prior experience with biologics or vaccines is required.
Advanced degree in Pharmacy, Chemistry, Biology, Medicine, or similar discipline.
Experience at a large pharmaceutical/vaccines company
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 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 as part of developing, mentoring, and coaching junior staff.
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 Director within North America Regulatory Affairs, you will have a unique leadership opportunity to join a team preparing for new product approval and launch in the US; will assume responsibility for US regulatory strategic guidance and execution for end-to end tasks (from FDA interactions to launch support to variation planning).
You will have responsibility for providing Regulatory CMC and Clinical Development advice and execution for products under review at FDA. Will serve as lead US RA contact and US agent for GSK product(s) to FDA and will serve as expert for US regulatory requirements and strategy to GSK teams.
The purpose of the job is to:
- Provide input to/manage regulatory activities in order to obtain US licensure for commercial products as rapidly as possible, with the best possible label, and to maintain these authorizations.
- Determine from a strategic and scientific perspective the content of relevant sections (technical/non-clinical (NC), clinical/labelling and/or procedural) of project/product specific documents submitted to FDA (e.g. BLA, sBLA, Q&A, scientific consultations, PSPs, INDs, etc.) and ensure that these documents meet high scientific standards and regulatory requirements. Responsible for one or more specific (clinical/labelling, CMC/NC and/or procedural) section(s).
- Provide support in compiling/writing US relevant sections of briefing documents for internal governing bodies and other relevant internal documents (e.g. Global Regulatory Plan, Key Message Summary (KMS), etc.). Responsible for one or more US specific sections (clinical/labelling, CMC/NC and/or procedural).
- 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
Additional ongoing responsibilities of the role;
- 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.
- Provide input into the asset specific regulatory strategy for US
- 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 into the Global Regulatory Plan (GRP) for US specific aspects of (clinical/labeling, technical/NC and/or procedural) sections.
- Compile/write/review high quality project/product specific regulatory documents to be submitted to FDA (for clinical/labeling, CMC/NC and/or procedural) and ensure that those documents meet regulatory requirements.
- 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) for resolution within global teams and to NARA leaders.
You may apply for this position online by selecting the Apply now button.
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