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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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This position will report to the Senior Vice President, General Counsel Commercial and and will require you to work in a matrix setting in a fast paced, rapidly growing organization, partnering effectively with various stakeholders, including with colleagues in across the Commercial Legal team as well as Medical Affairs, Commercial, Regulatory, Ethics & Compliance, Privacy and other expertise areas at Alnylam.
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Influences management/senior management decisions and is viewed as the Subject Matter Expert on CS decisions impacting a program and potentially the Medical/Scientific Affairs groups. In collaboration with the Clinical Affairs Lead and Medical/Scientific Lead, prepares strategy decisions, presents, and discusses data at relevant team, governance, external consultants, KOL and potentially regulatory meetings.
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A thorough understanding of global drug development functional areas including preclinical, clinical, regulatory affairs and manufacturing. Knowledge of GLP/GCLP and GCP global regulatory requirements for clinical trial submissions (USA, UK & EU), understanding of 21CFR Pt. 11 with respect to clinical systems (QMS.
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The Assistant Vice President for Institutional Effectiveness will translate complex data into actionable insights, thereby empowering various departments, including academic affairs, student affairs, student services, finance, and facilities, to make data-driven decisions.
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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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This position manages regulatory adherence and all 340B related policies and procedures and is responsible for HRSA OPAIS Database accuracy. Coordinates all 340B related meetings with Senior Leadership, IT, Finance, Legal, Pharmacy Directors and 340B Stakeholders.
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As an Anti-Money Laundering (AML) Compliance Senior Manager, you will lead the AML program strategy, including reporting, advisory, and governance, to ensure industry-leading performance and compliance with all regulations.
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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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The role will support management of the processes of onboarding managers, investors, KYC/AML requirements, Bank and SEC regulatory reporting, Fund Audits, and Client Reporting. Responsible for addressing KYC/AML and all regulatory elements for Clients.
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As the Senior Manager, Semiconductor Partnerships & Ecosystem within our Strategic Semiconductors team, you will drive the development and management of our semiconductor vendor ecosystem, focusing on next-generation technology, product innovation, and strategic partnerships.
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Ensures ongoing compliance with all applicable regulatory agencies for department section (including but not limited to: CLIA, TJC, OSHA, DPH, HCFA, FDA, AABB, NCCLS). Participates in hospital-wide Quality Assurance Program as designed by regulatory agencies, by the BMC Quality and Patient Safety Department or by the departmental/sectional Quality Assurance Policies.
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Primary Responsibilities:This role involves working closely with scientists and regulatory affairs departments on various nonclinical regulatory documents. The Scientific Editor's responsibilities will be:Collaborate with scientists on nonclinical regulatory documents such as Investigator Brochures, Nonclinical Study Reports, Annual Reports, CTAs, INDs, and NDAs. Assume lead scientific writing responsibility on projects, utilizing regulatory and publication documentation expertise.
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Compliance and Regulatory Oversight: In collaboration with organizational risk management and compliance leadership, ensures compliance with all federal, state, and local regulations governing FQHC operations, including HRSA, DPH, CMS, HIPAA, and NCQA PCMH requirements and standards.
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Outside of the Platform, the RWE Oncology Lead will work with leaders from Biostatistics & Data Management, Global Regulatory Affairs, Clinical Pharmacology / Pharmacometrics, HEOR, Legal/Compliance, and others to achieve research and business objectives.
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senior manager regulatory affairs jobs Company: Abbvie in Cambridge, MA
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