Regulatory Affairs Director, US Regional Expert

Regulatory Affairs Director, US Regional Expert
+ Requisition ID:WD86644
+ Position:Full time
+ Open date:Aug 5, 2016 2:19 PM
+ Functional area:Regulatory
+ Location:Maryland
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+ + Required degrees:Masters
+ Experience required:8 years
+ Relocation:Yes
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Basic qualifications:Advanced scientific degree
Life Science Degree
Understanding of scientific basis for clinical development, endpoints, and product CMC is critical to role.
8+ years direct experience in US regulatory affairs, or appropriate relevant experience in scientific function in vaccine industry, combined with at least 4 years direct RA experience.
Broad knowledge across all stages of product development is required and covers scientific as well as regulatory expertise. Direct experience in clinical regulatory affairs as well as CMC regulatory affairs for licensed biologic product or vaccine is essential. Some prior experience with vaccines is required.
Experience of presenting to expert groups / regulatory authorities and of negotiating with and influencing these groups to shape the development of a product. The job holder must have first-hand experience of working directly with FDA.
Preferred qualifications:PhD or equivalent
Biology, Chemistry, Immunology, etc,
Experience within large Pharma industry is preferred.
? Recognized excellent communication skills, both oral and written. Excellent knowledge of spoken and written English
? Evidence of proactive leadership to identify issues and maximize opportunities. Ability to quickly assimilate facts and data and develop an understanding of complex matters.
? Experience in the development and licensure of vaccines in the US, Europe, and other major markets, with a special emphasis on US.
? Self-motivated with the ability to work independently, to develop credibility with colleagues within and outside GSK
? Ability to resolve problems through resourceful use of information and contacts
? Enterprise thinking ? needs to understand the constraints and drivers of other functions and the potential impact on RA, including how RA may facilitate in achieving the overall goal.
Details: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 authorisations.
? 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 optimise 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 organisation 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.
LI-GSK
Contact information:
You may apply for this position online by selecting the Apply now button.
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GSK is an Equal Opportunity/Affirmative Action Employer. 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.
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