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Acumen Pharmaceuticals is seeking a Director, CMC Regulatory, reporting to the Vice President, Regulatory Affairs, to lead the development, implementation, and execution of CMC regulatory strategy, including global submission strategy for investigational applications, clinical trial support, compliance, marketing application strategy, and CMC change management, ensuring compliance with global regulations (e.g., FDA, EMA, MHRA, HC, PMDA, CFDA, ANVISA.
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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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The Sr. Medicare Compliance Program Manager is a key member of the Legal, Regulatory Affairs and Compliance team to support the organizations Medicare Advantage line of business. Advises Medicare Compliance Officer regarding the development and implementation of regulatory strategy, potential areas of regulatory concern, and new government/regulatory developments.
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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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Develop effective collaborations with research project leaders and projects team members, including biostatistics, regulatory affairs, clinical pharmacology, clinical scientists and development operations.
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Associate Director, Public Affairs will serve as a critical Policy & Advocacy team member with responsibility for relations and collaboration with City and State legislators and regulators who make legislative, regulatory policy, and public policy decisions.
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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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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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Additionally, the VP, Regulatory Affairs and Quality will be responsible for hiring a Director, Regulatory Operations, to report to them. The Vice President, Regulatory Affairs and Quality will work collaboratively with colleagues across the company, and with outside partners, to design and execute global registrations strategies for all Xilio products, including initial regulatory efforts on pipeline programs.
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You will collaborate with colleagues in other functions including Study Physician, Patient Safety, Regulatory Affairs, Clinical Operations, Translational, CMC, and early development groups.
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10+ years of relevant regulatory/industry experience in biotech or pharmaceuticals with at least 8 years as the global Regulatory Affairs lead representative on project development teams that have led to marketing authorization.
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You will report to our Head of Regulatory Affairs and work side by side with your research and development colleagues to develop and execute innovative regulatory strategies for our development programs (from FIH through late-stage clinical programs), including the implementation of non-clinical and clinical regulatory strategy for relevant products.
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Reporting to the VP of Program Strategy & Management, this person will work collaboratively to manage and integrate diverse R&D activities including but not limited to, preclinical research, clinical development, CMC, regulatory affairs, new product planning, business development and finance.
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Minimum of 10 years of experience in global regulatory affairs, with a focus on CMC, in the pharmaceutical or biotechnology industry. Maintain effective communication with internal and external stakeholders to ensure alignment and understanding of CMC regulatory strategies and requirements including change control.
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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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regulatory affairs jobs Company: Citi in Waltham, MA
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