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What we look for: A scientific degree with directly relevant professional experience in global CMC regulatory affairs and CMC technical areas of at least 20 years with a BA/BS, MA/MS, PhD or PharmD. Demonstrated organizational leadership skills at both functional and enterprise levels.
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Job Title: Senior Manager, CMC Regulatory Affairs, BiologicsDuration: months (we would like to start with months, with the potential to extend if the person is highly competent and a good resource for our team)Location: Remote but preference is to have a candidate available to be onsite at the Foster City, CA offices - days if possible RESPONSIBILITIES MAY INCLUDE.
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Senior Manager, CMC Regulatory Affairs, Biologics. Extensive interaction with departments outside of CMC Regulatory Affairs to define strategy and submission plans. An in-depth knowledge of ICH and regional CMC regulatory requirements, and an understanding of current global and regional trends in CMC Regulatory Affairs.
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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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The Project Manager, CMC Regulatory Affairs will be responsible for the CMC regulatory activities in the investigational, late phase development and/or early commercial lifecycle management of GSK products.
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The purpose of this position is to provide advanced-level administrative and project coordination support to the VP, External Affairs and the external affairs team at Nicor, responsible for regulatory and legislative affairs.
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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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Two (2) years of progressively responsible experience in regulatory affairs, legislative affairs, or energy policy at an electric utility, regulatory agency, or legislative office.
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Experience representing CMC regulatory affairs on regulatory and cross functional teams. Significant experience in CMC Regulatory Affairs; strong verbal and written communication skills; experience in leading and preparation of regulatory submissions.
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Liaise with colleagues in Regulatory Affairs therapeutics teams, local Affiliates, Regulatory Operations, Regulatory Project Management and third-party local agents to develop filing plans and deliver submissions to agreed priorities and timelines.
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Significant experience in Regulatory Affairs CMC and/or relevant pharmaceutical industry experience. Act as the regional CMC Regulatory lead for assigned products and territories within a global matrix team, contributing to global CMC regulatory strategies for the International markets.
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Proven strategic thinking skills, with a proven track record for developing global CMC regulatory strategies in multiple markets simultaneously. A proven ability to co-ordinate the preparation of a variety of CMC regulatory documents in collaboration with other functions.
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Experience with Veeva Vault, including RIM; global regulatory expertise. Maintain a current awareness of CMC registration requirements in each of the International regions and communicate key regulatory intelligence to the organization on a timely basis.
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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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UT Southwestern Medical Center is hiring for Immigration Specialist, Office of International Affairs Works to provide advisory, guidance, and administrative skills throughout several phases of immigration process in Office of International Affairs.
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regulatory affairs jobs Company: S P Global in CT, Nebraska
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