This job has expired

Senior Mgr, Global Regulatory Affairs

Employer
GSK
Location
Rockville, MD
Salary
Competitive
Closing date
May 22, 2022

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Discipline
Other, Legal/Regulatory Affairs
Organization Type
Pharma
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Site Name: USA - Maryland - Rockville Posted Date: Apr 13 2022 As Senior Manager, Global Regulatory Affairs you will have global responsibility (for Regulatory Affairs) of given activities for a Project/Product within GSK Vaccines. The purpose of your job is to: Be the point of contact for FDA (i.e. US agent role) for specific vaccines Provide regulatory input for one or more specific sections of certain/all development stages of the project/product within a given product portfolio. Determine from a strategic and scientific perspective the content of relevant sections (technical/non-clinical (NC), clinical/labelling or procedural) of project/product specific documents submitted to FDA (eg. BLA, sBLA, Q&A, scientific consultations, etc.) and ensure that these documents meet high scientific standards and regulatory requirements. Responsible for one or more specific (clinical/labelling and/or technical/NC and/or procedural) section(s). Ensure, from an RA perspective, the execution of the product development regulatory strategy in order to ensure a complete and rapid development of the asset, for one or more sections (clinical/labelling and/or technical/NC and/or procedural) Provide input to/manage regulatory activities in order to obtain Marketing Authorizations for commercial products as rapidly as possible, with the best possible label, and to maintain these authorizations. Provide support in compiling/write briefing documents for internal governing bodies and other relevant internal documents (eg Global Regulatory Plan, Key Message Summary, etc.). Responsible for one or more specific sections (clinical/labelling and/or technical/NC and/or procedural). Support the Global Regulatory Lead in providing robust regulatory advice and plans to the various project teams and advisory bodies to ensure that the business needs are in compliance with regulations and/or regulatory advice received from the agency. May act as lead within the project, being accountable for the overall delivery of project-related activities, in collaboration with the members of the team. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following: Participate to project/product-related discussions and provides strategic, scientific and RA input, for all parts of RA aspects of given project topline and in depth on clinical/labelling or technical or procedural aspects. Provide support to the Global Regulatory Lead (GRL) for key regulatory activities pertaining to a project/product. Coordinate (for one or more specific (clinical/labelling and/or technical/NC and/or procedural) sections) the determination of key messages for product/portfolio specific regulatory documents to be submitted to Authorities, in collaboration with the GRL Develop and motivate collaborators (within RA team and in multidisciplinary teams) to achieve quality output, accountability, and recognition across the organization and towards the regulatory authorities. Ensure planning and proper organization of activities (for one or more of RA specific activities within clinical/labelling or technical/NC or procedural) in line with the overall project plan and RA milestones. Provide support to the GRL to assure efficient interactions with the regulatory authorities to achieve on-time approvals of GSK Vaccines submissions for the asset(s). In collaboration with the relevant RA functions, as appropriate, escalate gaps in resources to ensure the execution of the agreed RA plan to the GRL. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Master's Degree in General Science or Life Science Degree. 6+ years significant experience in regulatory affairs, or appropriate relevant experience. 6+ years' experience in the lifecycle management of vaccines Preferred Qualifications: If you have the following characteristics, it would be a plus: Advanced scientific Degree (Ph.D or M.D) in Pharmacy, Chemistry, Biology or Medicine Health Science. Strategic thinker - ability to provide input into regulatory strategy and evaluate potential impact on overall project/product strategy. Ability to identify and escalate issues to the GRL and to propose mitigation strategies, maximize opportunities, with proven ability to develop collaborative relationships and have high impact and influence 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 Good presentation skills to ensure that GSK Vaccines regulatory voice is clearly articulated and heard in the various cross functional teams. Good influencing skills. Broad knowledge is required and covers scientific as well as regulatory expertise. Ability to coordinate and execute regulatory strategy for a given project/product. Ability to work independently and take decisions with minimal supervision. Able to input into the Company's regulatory positioning and write /critically review key documents targeting internal or external key audiences. 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, talent and technology 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. 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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