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Within Global Regulatory Affairs, our Chemistry, Manufacturing and Controls (CMC) organization provides regulatory leadership to CMC development teams and the Pharma Supply Chain organization to enable approval of new medicines and uninterrupted supply of our medicines to patients.
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Prior pharmaceutical industry experience and a minimum of 8 years in CMC Regulatory Affairs for Associate Director. Reporting directly to the Senior Director CMC of Regulatory Affairs, the (Associate) Director of Regulatory CMC will be responsible for the development of regulatory CMC submissions.
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Work closely with NGS production, Quality and PreClinical Genotox for compliant execution of genotoxicity data packages in support of regulatory filings and clinical programs. Interact with Health Authorities, in writing and verbally, including pre-submission (e.g., pre-IND), scientific advice filings, IND or CTA, meeting briefing books, or other requests from global regulatory authorities.
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At least 3-5 years of relevant experience in the pharmaceutical industry or a regulatory authority CMC review capacity including at least 3 years of experience in Regulatory CMC and preferably 2 years professional experience in pharmaceutical manufacturing, analytical development, or quality assurance/control or related technical field.
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Dragonfly Therapeutics is seeking a Senior Director, reporting directly to the Senior Vice President, Head of Regulatory Affairs, to join the regulatory team within our Regulatory Affairs organization.
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The Regulatory CMC Lead is the primary global contact for Regulatory CMC activities associated with the program and will report to the Regulatory CMC Antisense Oligonucleotide Team Lead.
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This will provide valuable insight into how regulatory affairs into the overall business strategy of the company. Intern may be asked to participate in team meetings and projects related to regulatory affairs.
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Experience in providing regulatory CMC strategy for submission of clinical trial application (IMPD/IND) and marketing authorization application (NDA/MAA) for small molecule development compounds, including chemical drug, peptide and oligonucleotide.
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The Manager/Senior Manager of CMC Regulatory Affairs will be responsible for supporting commercial CMC and GMP activities for contracted manufactured products and Alkermes' European office.
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Strengthen internal gene therapy CMC capability by working with internal stakeholders and external partners to evaluate and enable gene therapy related GTP/GMP facilityLead 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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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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Strong knowledge of pharmacokinetics and pharmacodynamics principles, immunogenicity, modelling and simulation, Model-Informed Drug Development, ADME Concepts, and regulatory clinical pharmacology requirements to support clinical development and regulatory submission.
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Manage CRO interactions for timely DMPK study execution; support regulatory document preparation and presentation/publication strategies. Strong understanding of PK/ADME assays, methods, and models, as well as expertise in managing CROs and knowledge of regulatory guidance's.
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Collaborate with Regulatory Affairs to ensure appropriate reporting of pharmacovigilance and drug safety information to regulatory agencies and prescriber community. 6+ years' experience in Drug Safety and Pharmacovigilance in pharmaceutical or biotech company, CRO or regulatory agency within Drug Safety/Pharmacovigilance, with both investigational and marketed products.
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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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regulatory job Title: sr affairs associate in Lexington, MA
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