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Interact with internal cross-functional teams, including Analytical Development, CMC, Supply Management, Regulatory Affairs, Program Management and Quality Assurance, as well as with Alpine's/Vertex network of external CMOs/contract labs to support company's clinical programs.
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As part of the Regulatory Affairs CMC team, you will report to the Executive Director and Head, CMC Regulatory Affairs – Pharmaceuticals. Join Takeda as a Senior Director, GRA - CMC Pharmaceuticals- Small Molecule where you will establish collaboration with Global CMC teams and leadership through networks and enable CMC regulatory team’s success in meeting goals/objectives.
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The primary role of the Director, Regulatory Affairs - CMC is to create and/or manage contributions from others for CMC regulatory submission documents. This position reports directly to the Senior Director, Head of Regulatory Affairs - CMC. The Director, Regulatory Affairs - CMC will be responsible and accountable for CMC submission documents while successfully up-holding the vision for the function and help mentoring junior team members.
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The Director will chair the respective neurology TA Global Publications Team as well as engage with cross-functional partners including but not limited to research, clinical development, marketing, market access, medical affairs, regulatory affairs and biostats.
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The Director, Special Investigations Unit (SIU) will report to Sr. Vice President, Legal, Regulatory Affairs and Compliance and is responsible for supporting the prevention, detection, investigation, reporting, and when appropriate, recovery of money related to health care fraud, waste, and abuse.
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Support state level government affairs relations including staying up to date on current issues and trends, assistance in arranging meetings as appropriate and making connections on behalf of the bank.
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As a pivotal leader within the Division of Student Affairs, the Director of Residence Life reports to the Senior Associate Dean of Students and oversees a large and multifaceted residential program.
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Skilled in writing and supporting the generation of regulatory documents related to Bioanalytical package ( briefing book, assay description, CTD modules for IND/MAA etc) and regulatory interactions ( with FDA CDRH, EU notified bodies.
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Provide Regulatory Operations leadership during the implementation process of Veeva PromoMats in preparation for eCTD submissions to OPDP. Bachelor’s degree and/or Master’s degree with a minimum of 10 years relevant experience in pharmaceutical/biotechnology Regulatory Operations and project management.
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Collaborate with key stakeholders across the organization, including clinical operations, regulatory affairs, data management, and IT, to assess user needs, gather requirements, and develop tailored solutions to address business challenges.
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Certified Anti-Money Laundering Specialists (CAMS), Certified Internal Auditor (CIA), Certified Information Systems Analyst (CISA), Certified Regulatory Compliance Manager (CRCM) or other relevant professional certification.
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Organizational Administration Serves as the principal liaison to other MGB and hospital departments and services such as: Patient Care Services; Network Development; Marketing; Office of General Counsel; Development; Public Affairs and Communications; Research Management; Budget and Finance.
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The role involves providing legal counsel to blockchain technology companies, financial institutions, and digital asset exchanges on various securities law issues, private placement agent requirements, custody rule requirements, cross-border regulatory matters, and responding to FINRA and SEC regulatory inquiries.
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Position SummaryThis position is a key leadership role for the development of the In Vivo franchise at CRISPR. Reporting to the Senior Director of Regulatory Affairs CMC, you will work closely with cross-functional teams and partners to bring multiple novel therapies to patients.
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Collaborates with other functional work teams e.g., Preclinical, Clinical, Medical Affairs, Manufacturing and Quality Control, providing regulatory guidance to aid in preparing, reviewing, and approving of regulatory NDA/IND/CTA/IMPD submissions materials.
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regulatory affairs jobs Title: principal Company: Parexel in Watertown, MA
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