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Senior Manager, Facilities, Global Regulatory Affairs

Company: GSK Poland
Location: Rockville
Posted on: February 25, 2021

Job Description:

Senior Manager, Facilities, Global Regulatory Affairs

  • Rockville, Maryland
  • Regulatory
  • 277507 Job description Site Name: USA - Maryland - Rockville
    Posted Date: Jan 21 2021
    Are you interested in a regulatory affairs role that allows you to accelerate regulatory compliance across the globe? If so, this Senior Manager, Facilities, Global Regulatory Affairs could be an ideal opportunity to explore.The Senior Manager, Facilities will be responsible for regulatory submissions, interactions with FDA, and strategy for various US products (including Covid-AS03 related assets) regarding manufacturing facilities and equipment.Management of facilities and equipment matters required for the registration and life cycle for GSK Vaccine products including definition of the proper regulatory filing strategy, file preparation & submission and regulatory authorities' interactions for Assigned Projects/Sites in which GSK Biologicals vaccines are manufactured.For US FDA/CBER specific interactions (for instance submissions, consultations...), will function as the "legal agent" regarding Facilities, Equipment and Inspections.This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following---
    • Interact with internal project related teams, for Facilities related regulatory affairs aspects of a given project on technical aspects.
    • Participate in project/product-related discussions and provide strategic, scientific and regulatory affairs input, for Facilities related aspects of given project on technical aspects.
    • Provide input into the asset specific regulatory strategy on a global scale.
    • Provide support to the GRL via input and/or critical review of the facilities regulatory documents, Global Regulatory Plan(s) and/or Key Message Summaries.
    • 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).
    • Write/review/approve regulatory submissions before they are submitted to regulatory agencies, mainly to the US FDA (CBER)
    • Assess the regulatory impact of Regulatory Facilities related Changes pertaining to approved commercial products
    • Be aware of changes in regulatory guidelines and their impact on regulatory strategy for the particular asset(s).
    • The job also includes providing support (coaching, mentoring, lead) to several Managers and Specialists in the team. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals:
      • Bachelor's degree in Chemistry, Engineering, Biology, or related field.
      • 6+ years significant experience in regulatory affairs or appropriate relevant experience in scientific function combined with at least 3 years direct RA experience
      • Knowledge and experience in US regulations pertinent to CMC/Establishments/GMP
      • Knowledge and experience in CMC/Establishments/GMP/ Equipment Validations Preferred Qualifications: If you have the following characteristics, it would be a plus:
        • Master's degree in Chemistry, Engineering, Biology, or related field.
        • Pharmaceutical development or regulatory affairs experience with biologics and vaccines preferred.
          • Critically reviewing, while ensuring rigorous scientific content/quality/compliance, key documents targeting internal or external key audiences, including but not limited to annual reports, CBE-30 and Prior Approval Supplements, equipment validations,briefing documents, key meeting summaries, and BLA and IND establishment modules.
          • Program Management - Identifying and escalating regulatory or programmatic issues while proposing mitigations strategies and solutions/problem solving.
          • Effective time management, ability to clearly identify priorities and manage multiple tasks
          • Excellent organizational skills
          • Excellent written and oral communication skills
          • Ability to strategize, problem solve and influence
          • Experience in providing strategic advice on Facilities in cross-functional teams
          • Experience in interacting with external organizations pertaining to regulation of Facilities and QA
          • Knowledge and experience in regulatory requirements from a Global perspective (FDA/EMA/International)
          • Experience in QA/CMC strongly desirable
          • Clear leadership capability/potential Why GSK? Our values and expectations--are at the heart of everything we do and form an important part of our culture.These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
            • Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigour and risk.
            • Managing individual and team performance.
            • Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
            • Implementing change initiatives and leading change.
            • Sustaining energy and well-being, building resilience in teams.
            • Continuously looking for opportunities to learn, build skills and share learning both internally and externally.
            • Developing people and building a talent pipeline.
            • Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation.
            • Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally.
            • Budgeting and forecasting, commercial and financial acumen.*This is a job description to aide in the job posting, but does not include all job evaluation details.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.Important notice to Employment businesses/ AgenciesGSK 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. This is our global website, intended for visitors seeking information on GSK's worldwide business. Our market sites can be reached by visiting our market selector .

Keywords: GSK Poland, Rockville , Senior Manager, Facilities, Global Regulatory Affairs, Executive , Rockville, Maryland

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