The Role:\
Reporting to the Director Quality Systems & Compliance the AD Regulatory Compliance will be responsible to be the liaison function between Quality and the Regulatory CMC functions of Moderna. The role will implement and continuously improve required processes to ensure the compliance of Moderna\\xe2\\x80\\x99s product with the registered dossiers. \
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\Here\\xe2\\x80\\x99s What You\\xe2\\x80\\x99ll Do:\
Implement, execute, maintain and improve processes for sharing relevant dossier parts amongst the Moderna network and with 3rd parties. \
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Implement, execute, maintain and improve the processes for assessing Deviations with potential impact to the registered details and ensure systematic implementation to ensure continuous compliance with the dossier \
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Provide assessments and guidance on regulatory compliance impact assessments of Change Controls, Specification Management, Deviations and other QMS processes as required. \
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Support quality-related information requests raised by partners/customers and International Health Authorities \
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Support review and approval of regulatory documentation to improve compliance including compliance checks as required \
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Act as a Subject Matter expert for dossier content related questions and provide training and learning to the INTL team on the content and interpretation of the dossiers. \
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Provide cross functional quality leadership and act as a GXP compliance subject matter expert on technical matters involving product examination, testing and disposition, quality investigations, validation, data integrity, and in business matters involving facility and laboratory operations. \
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Work collaboratively with the digital team on the GXP integrated digital landscape to support all electronic quality systems, the utilization of data to accelerate and inform process and system performance and value stream roadmaps for long range planning. \
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Support and lead programs strengthening the regulatory compliance of Moderna and support continuous improvement for the rapidly expanding GXP international environment. \
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Engagement in external committees to systematically influence the industry \
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\Here\\xe2\\x80\\x99s What You\\xe2\\x80\\x99ll Bring to the Table:\
12 years+ experience in Regulatory Compliance or equivalent functions in GxP-regulated Pharmaceutical Industry \
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Bachelor\\xe2\\x80\\x99s degree or higher, preferably in Sciences or Engineering \
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Proficient in English, additional languages are a plus \
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Proactive Team Player with strong interaction skills who will flourish in a dynamic environment \
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Ability to manage stakeholders at all levels and achieve in a matrix organization \
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Proven track record in management of regulatory dossier compliance reviews \
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Proven track record in solution-oriented handling of complex regulatory impacting Change Controls and Deviations \
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Travel up to 20% \
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Moderna offers personalized benefit programs and well-being resources as unique as our global workforce so employees can do their best work. \
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We recognize and appreciate your diverse needs and interests and do our best to support you at work and at home with: \
Quality healthcare and insurance benefits \
Lifestyle Spending Accounts to create your own pathway to well-being \
Free premium access to fitness, nutrition, and mindfulness classes \
Family planning and adoption benefits \
Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, and a discretionary year-end shutdown \
Educational resources \
Savings and investments \
Location-specific perks and extras! \
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The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work. \
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About Moderna \
In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna\\\'s capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic. \
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Moderna\\\'s mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com . \
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Moderna is a smoke-free, alcohol-free and drug-free work environment. \
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