Are you interested in a highly visible Global Regulatory Affairs role driving
the regulatory strategy
for GSK new Pneumococcalprogram at the cornerstone of GSK's adult and pediatric
offer? If so this opportunity might be for you !
This role will provide YOU
the opportunity to lead key activities to progress yourcareer, these responsibilities include some of the following:
- Provide input to/manage regulatory activities in order to obtain US licensure for products currently in development 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
- 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 Strategy (GRS) 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.
- 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.
General information :
Why you? Basic Qualifications:
- Primary location: US GSK sites - US East Coast
- Growth opportunity: depending on performance and interest, US and other regions
- People management: no
We are looking for professionals with these required skills to achieve our goals:
- Bachelor's degree in Chemistry, Biology, Biochemistry, or similarly applicable discipline
- Minimum 10 years of tangible experience in Regulatory Affairs i.e. Clinical Development, Regulatory at all stages of product development and CMC
- Proven experience in liaising with FDA
- Experience in Clinical Regulatory Affairs and CMC regulatory affairs for licensed biologic product or vaccine
- Experience in IND and BLA regulations and US regulations pertinent to product development and licensure
If you have the following characteristics, it would be a plus:
- Ability to work in a matrix environment
- Strategic thinking
- Team work
- Engage and network
*LI-GSK Why GSK ?
At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Health, strengthening our leadership, and transforming our commercial execution. Now, we're making the biggest changes we've made to our business in over 20 years. We're on track to separate and create two new companies in 2022: New GSK
with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands.
With new ambition comes new purpose. For New GSK, this is to unite science, technology and talent to get ahead of disease together
- all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive.
Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that is ambitious for patients
- so we deliver what matters better and faster; accountable for impact
- with clear ownership of goals and support to succeed; and where we do the right thing.
So, if you're ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead Together.
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.
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