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Senior Director of Regulatory Affairs and Strategy will develop and implement comprehensive regulatory strategies and oversee daily regulatory affairs activities, including the areas of clinical research, CMC, regulatory operations, nonclinical study requirements, and regulatory compliance to support the successful development, approval, and marketing of Marengo products.
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This role collaborates cross-functionally with key cross-functional partners including other GMA functions, Clinical Development/Operations, Regulatory Affairs, Corporate Communications/IR, Legal, Market Access and Commercial, and Research.
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O Provides communications between Global Regulatory Affairs CMC and partners within GRA and across and outside of the organization, as evidenced by the successful achievement of CMC regulatory milestones according to project plans, and by the level of partner satisfaction with the support provided by the group.
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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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Serve as legal reviewer on promotional and medical review teams and partner with Commercial, Medical Affairs, and Regulatory Affairs to help ensure compliance, consistency, and accuracy in connection with promotional, medical, and disease awareness materials, publications, scientific and medical meeting materials, training materials, and materials for advisory boards, speaker programs, patient programs and the like.
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Regulatory Affairs Manager *PC Regulatory Affairs - Waltham MAAt Miltenyi Biotec, 3, employees worldwide develop pioneering solutions for biomedical science and the clinical application of cell therapies.
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This 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 role functions in a company matrix team environment interacting with several key stakeholder groups including; Clinical Development, Pharmacovigilance, Regulatory Affairs, Quality Assurance, Manufacturing, Commercial, Medical Affairs, Research and Legal.
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PharmaLex is one of the largest worldwide providers of consulting services in the following focus areas: Quality Management & Compliance; Development Consulting & Scientific Affairs; Regulatory Affairs; and Pharmacovigilance, Epidemiology and Risk Management.
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Over 15 years of progressive advancement within global regulatory affairs in the pharmaceutical /biotech industry. The Vice President, Regulatory Affairs & Quality is in charge of providing subject matter expertise on all matters related to FDA and global regulatory requirements, as well as leading the growth and responsibilities of the regulatory and quality department.
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A Bachelor's degree required with a minimum of 4 years of regulatory affairs experience; or a Master's degree with a minimum of 3 years of regulatory affairs experience; or a Doctorate degree with a minimum of 1 year of regulatory affairs experience within the pharmaceutical/biotech industry.
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We are accountable for enabling our programs in early research to reach development candidate nomination through regulatory filing and into clinical trials. How you will Achieve More with Intellia:Intellia is look for a Director, Genotoxicity Regulatory Lead to support the advancement of genome editing products into the clinic.
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This investigation includes but is not limited to a criminal, civil litigations and regulatory review, employment, education, and credit review (role dependent). Provide thought leadership in partnership with Government Affairs to advocate on behalf of Fidelity and its customers.
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Offering expert guidance from concept-through-commercialization, including product design and engineering, preclinical and clinical development, data management, market access, regulatory affairs and quality assurance, Veranex enables accelerated speed to market, controlled development costs, development risk mitigation, and accelerated market viability assessment.
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Provide expert-level legal counsel and assistance to projects and initiatives of Regulatory Operations and other departments and support them in achieving their goals, including supporting FINRA's examination and enforcement programs to further reflect a holistic approach to member firms' business operations.
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regulatory affairs jobs Title: principal consultant Company: Parexel in Watertown, MA
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