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A scientific degree with directly relevant professional experience in global CMC regulatory affairs and CMC technical areas of at least 15 years with a BA/BS, MA/MS, PhD or PharmD. Lead the execution of global CMC regulatory plans, including overseeing the submission and approval process in close partnership with other functions in PDM, Regulatory Affairs, and Clinical Development.
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Coordinate CMC portfolio plans with global company plans, internal manufacturing site production plans, contract manufacturing production plans, clinical development plans, CMC regulatory filings Focus on continuous improvement of team capabilities by ensuring that partner team leads have the opportunity for training and development to excel in their role as functional representatives and cross-functional team members.
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Work closely with all related internal functions including Engineering, Manufacturing, MSAT, Technical Development, Quality, Compliance, Legal, and Regulatory Affairs. Supports regulatory projects, business continuity management, incident response teams, and CMC/Process Development initiatives.
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The La Vida Dominican Project Director works closely with the Vice President for Academic Affairs and affiliated faculty and staff of La Vida Dominican program and the Dominican campus to oversee and coordinate project activities and integrate holistic support services for students and community into Dominican planning and processes.
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MedPro is one of the largest recruiters of therapists and nurses from outside the U.S. MedPro currently has contracts with numerous organizations to service a multitude of facilities in the U.S. The company counts among its clients prominent healthcare facilities and organizations such as the Department of Veterans Affairs,HCA, University of Miami Hospital, and Tenet Healthcare.
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Requires successful track record of at least 10 years of experience providing legal advice on relevant areas of the law (e.g., corporate, privacy, health care regulatory, litigation, contracts, et al) at a top law firm or in-house corporate law department.
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Plan, prioritize, assign, supervise, review, and participate in the work of staff responsible for providing services and activities in an assigned section and/or functional area in the Planning Division including in the areas of current or advanced planning, zoning administration, affordable housing, and/or special projects.
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The Director, US Achondroplasia HCP Marketing Lead is responsible for overarching HCP vision, strategy and tactics for the cross-functional brand team for Voxzogo in achondroplasia and lifecycle opportunities in the US. They must be a seasoned leader who can influence without direct reporting relationships across all key stakeholder teams in the US (sales, reimbursement hub, market access, global product strategy, medical affairs, compliance, learning and development, etc.
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Active listening and strong customer service skills are highly desirable traits that will help the Principal Civil Engineer candidate be successful. Our Highly Qualified Candidate: The highly qualified Principal Civil Engineer candidate will be an experienced manager who is able to communicate effectively and collaborate with a diverse team of professionals, project stakeholders, and members of the public.
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This position requires interaction with the following teams: Promotional Review Board members (Commercial, Compliance, and Medical) U.S. and Global Brand Management U.S. Field Commercial Learning and Development In-house Creative Compliance and Regulatory Operations Finance Information Management Rare Connections HUB External vendors: marketing and advertising agencies, medical education agencies, and consultants.
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The Agricultural Marketing Service (AMS), Livestock & Poultry (LP) program is responsible for formulating and administering policies for marketing services and regulatory activities related to commodity grading and certification for meat, eggs and poultry.
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Provides expert dissolution test method development to meet the drug product profile for orals in accordance to regulatory guidance. The Principal Scientist designs and performs complex analytical experiments and procedures to support drug development.
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Serve as the technical lead and core team member on projects and interact with global clinical, manufacturing, production, quality, regulatory, project management, legal, claims and strategy and marketing personnel.
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Support the Supply Chain Operations department as the primary point of contact for Ready process and Inventory as well as partnering closely with the OPS, Quality, Regulatory, CMO's, Finance, and Projects group.
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If the regulatory minimum wage exceeds the minimum indicated in the pay range below, the regulatory minimum wage will be the minimum rate applied. These ranges may differ in other areas and could be subject to variation based on regulatory minimum wage requirements.
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regulatory affairs jobs Title: principal Company: Parexel in Novato, CA
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