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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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10 years industry experience; pharmaceutical companies, CRO or academic with at least 6 years experience directly in Regulatory Affairs or in CMC regulatory or role with CMC regulatory submission responsibilities.
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Balance reporting requirements to multiple constituencies including; Centene Corporation regional vice president, state health plan president, chief operating officers and Corporate regulatory and government affairs staff.
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Takeda Development Center Americas, Inc. is seeking a Manager, Global Regulatory Affairs CMC Submissions Management in Lexington, MA to establish global submission activities and timelines in partnership with global and cross-functional stakeholders in Pharmaceutical Science, GMS, Biologics and Small Molecule operating units, Regulatory Affairs, and QA. Up to 20% domestic travel required.
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Supporting the Head of U.S. Government and Regulatory Affairs and Head of the DC Office to develop and execute a Washington, DC public policy strategy with the U.S. Congress, U.S. Administration, and U.S. regulatory agencies.
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We are now looking for a Regulatory Data Office (RDO) Analytics and Reporting Senior Developer to join us in Global Regulatory Operations (GRO) within Regulatory Affairs. The jobholder will be a member of the RDO Analytics and Reporting group, which is specifically tasked with providing analytical and reporting services in support of the Regulatory Affairs business.
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Communicate regularly and effectively in a cross-functional matrix with development, origination, fundamentals, finance, and political & regulatory affairs staff to translate regulatory and market issues into business impacts and opportunities to benefit the position of Pattern's new and core business interests in MISO and other priority markets.
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Invenergy is seeking a knowledgeable and proactive Senior Manager for Government Affairs to support our growing Public Affairs team. As a Senior Manager, California Government Affairs, this individual will focus on Invenergy’s California government affairs activities for all aspects of Invenergy’s growing business.
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In this highly visible role, you will partner with a large, global pharmaceutical company and provide CMC regulatory strategy input and expertise in the area of investigational, new and marketed biologic and small molecule drug products to assigned project teams, to ensure client's products are developed/maintained in compliance with global regulatory requirements and guidances.
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The Sr. Director, Global Medical Affairs- Hemophilia is a critical member of the Medical Affairs and Patient Engagement leadership team and is responsible for defining the Global Medical Affairs vision, contributions to the integrated strategy (which also includes market access and marketing components) & tactics, and integrated evidence plan that support Spark’s late-stage product development and commercialization objectives through Roche.
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Oversees all talent billing & production advances with support from Business Affairs manager. Oversees Business Affairs / Talent manger. A minimum of 7 years of experience specific to the advertising industry in a Business Affairs Role.
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Job DescriptionInvenergy is seeking a knowledgeable and proactive Senior Manager for Government Affairs to support our growing Public Affairs team. This individual will work collaboratively with members of all departments within the company, including but not limited to Offshore Wind Development, Onshore Development, Origination, Transmission, Regulatory, and Environmental Compliance & Strategy.
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Team with business unit Regulatory Affairs Specialists (RAS) to provide regulatory support for new product introduction (NPI) and marketed products under MDD and MDR Regulation. As Principal Regulatory Affairs Specialist, you will develop and implement medical device regulatory strategies to obtain timely approvals from worldwide regulatory bodies.
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We invested in new offices, sector teams and practice groups including investor engagement; shareholder activism; governance; regulatory and public affairs, including geopolitical; crisis; litigation; social issues including climate change and diversity, equity and inclusion; cybersecurity, data and privacy; employee engagement; digital communications; opinion research and analysis, and; creative services.
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The Army public affairs specialist participates in and assists with the supervision and administration of Army public affairs programs primarily through news releases, newspaper articles, Web-based material and photographs for use in military and civilian news media.
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regulatory affairs jobs Title: regulatory affairs project manager Company: Abbott
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