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Regulatory Systems Lead

Rockville, MD
Closing date
Dec 3, 2021

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Other, Legal/Regulatory Affairs
Organization Type
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Site Name: USA - Maryland - Rockville Posted Date: Nov 1 2021 GSK currently has an opening for a Regulatory Systems Lead in Rockville, MD. In this role, you'll be responsible and accountable for ensuring approved product dossiers are maintained in a state of compliance with respect to the manufacturing, testing, storage and distribution operations at GSK Rockville Biopharm facilities. Key Responsibilities: Responsible for regulatory submission preparation & review of global submissions, variations/supplements for products produced by the Biopharm site. This includes both IND and approved commercial products. Support Response to Questions (RTQ's). Support Market Specific Requirements (MSR's). Support renewals. Responsible for reviewing change notifications from Vendors to assess regulatory impact. Support changes to site specifications Initiate change controls for new market submissions. Support Annual Reports for commercial products. Support Periodic Product Review reports for commercial products. Support change control assessments; provide advice and approval. Initiate RADARs and support Regulatory Implementation Strategy (RIS) meetings. Responsible for overseeing adherence to current regulatory requirements by managing monthly Quality Regulatory Intelligence (QRI) meetings. Management of Quality Alerts. Attend monthly Regulatory Community of Practice (CoP) forums. Support regulatory inspections from all health authorities. Participate in self-inspections to ensure PAI readiness. The incumbent is responsible for adhering and promoting GSK safety guidelines and procedures. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: BS/BA Degree 4+ years industry experience in biopharmaceutical/biologics manufacturing environment. 2+ years prior experience in regulatory functions. Preferred Qualifications: If you have the following characteristics, it would be a plus: Good understanding and interpretation of Global regulations pertaining to the manufacture, holding, and distribution of biopharmaceuticals/biologics. Extensive working knowledge of GSK marketed products (US & International) with emphasis on Chemistry, Manufacturing and Controls (CMC). Good working knowledge of regulatory affairs, including submissions/supplements/variations and approved dossiers. Demonstrated ability in conformance review of registered documentation and practices. Comprehensive knowledge and application of the Quality Management system (QMS). Excellent written and verbal communication skills. Demonstrate Project Management and organizational skills. Good working knowledge of applicable systems including electronic dossier submission systems 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: Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigor and risk. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Continuously looking for opportunities to learn, build skills and share learning. Sustaining energy and well-being Building strong relationships and collaboration, honest and open conversations. Budgeting and cost-consciousness *LI-GSK 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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