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Bachelor's degree (BA/BS) in a scientific discipline required and advanced degree preferred with a minimum of 10 years' experience in drug development/regulatory affairs and a minimum 8 years in CMC regulatory affairs.
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10+ years of pharmaceutical/biotech drug development experience with 5+ years of experience in global CMC regulatory affairs with working experience and content knowledge in CMC development of NCEs / small molecules.
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JOB DESCRIPTION Job TitleSr. Regulatory Affairs Specialist-CT/AMIJob DescriptionThe Senior RA Specialist will play a critical role in ensuring Philips Computed Tomography (CT) and Advanced Molecular Imaging (AMI) solutions are safe, reliable, and compliant through driving global regulatory strategy and regulatory roadmaps—understanding competitive claim landscape, legislative initiatives, and marketing strategy.
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With funding for the next 2 years, they are now seeking an exceptional physician leader to serve as Chief Medical Officer and build out their full R&D function including clinical development, clinical operations, regulatory affairs, biometrics, medical affairs and drug safety.
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As our Regulatory Affairs Manager, you will play a crucial role in our product development team by ensuring that all new and existing products comply with regulatory standards in the United.
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Experience working with and building strong relationships with cross-functional departments in business, marketing, hardware and software engineering, product and project management, process and analytical development, regulatory and quality.
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Reports to: Executive Vice President and Managing Director, Chief Counsel, Head of Global Regulatory Affairs. Position Title: Counsel/Senior Counsel, Regulatory Affairs (position title and compensation is commensurate with experience.
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Represent Regulatory CMC on cross-functional development/commercial teams and Regulatory Affairs teams. Responsibilities: Participate in the development of the CMC regulatory strategy for small molecules, biologics and cell therapy submissions.
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The senior leader, Cardiovascular Medical Affairs will have a strong understanding of all phases of product development, including preclinical development, clinical trial management, market preparation and launch readiness, post-launch marketing, post-approval studies, regulatory affairs, GCP and manufacturing compliance.
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Requirements: BSc or MSc level degree preferably within the life sciences (PharmD, PhD, or MD preferred) Minimum of 10 years of experience within Regulatory Affairs (Oncology experience preferred) Direct interaction/negotiation skills with regulatory authorities (e.g. FDA, EMA) A broad knowledge of development and life-cycle management is preferred.
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MS, MSJ, MBA +18 yrs relevant experience Global Clinical and Medical affairs, Pharma QMS Development and Management, Regulatory Affairs, Clinical Quality, GCP audit readiness Regulatory Inspections experience; orBS + 20 Yrs relevant experience Global Regulatory affairs, Pharma QMS Development and Management, Clinical Quality, GCP audit readiness, Regulatory Inspections experience.
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As part of the GRA CMC Pharmaceuticals, Oligonucleotides team, you will report to the Executive Director and Head, CMC Regulatory Affairs, Pharmaceuticals. In conjunction with members of the team, develop high quality clinical, commercialization and LCM submissions, using proactive regulatory CMC strategies and submit them as planned.
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Communications / Contacts Internal - Departmental staff, business unit leaders/representatives, accounting managers, treasury and finance personnel, regulatory affairs cost of service department staff; and BHE corporate consolidations External - Federal Energy Regulatory Commission (FERC), Corporate Noteholders, Kansas Dept of Health & Environment, Environmental Protection Agency, auditing firms, IRS, pipeline journals.
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You will need to work closely with the Vice President, Global Regulatory Affairs Oncology and Precision Medicine, and collaborate with the biomarker team and global/regional regulatory liaisons to provide Precision Medicine global regulatory guidance.
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This individual will also lead a wide range of complex government relations and public policy issues that include: execution of government affairs strategies that influence legislative and regulatory public policy; advocacy, through coalition building and grassroots influence, of PSE's interests before government; support of major PSE initiatives.
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regulatory affairs jobs Title: quality manager regional
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