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2-5 years of experience in regulatory affairs within the pharmaceutical or biotechnology industry, with a focus on regulatory operations. As the Regulatory Affairs Operations Specialist, Ad/Promo, you will play a pivotal role in ensuring regulatory compliance and operational efficiency within our organization.
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Takeda Development Center Americas, Inc. is seeking a Manager, Global Regulatory Affairs CMC Submissions Management in Lexington, MA to establish global submission activities and timelines in partnership with global and cross-functional stakeholders in Pharmaceutical Science, GMS, Biologics and Small Molecule operating units, Regulatory Affairs, and QA. Up to 20% domestic travel required.
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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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Must possess extensive knowledge of Regulatory Affairs as it applies to the product life cycle as well as other related processes gained from work experience. Regulatory Affairs Certification (RAC) desirable.
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Reporting to the Senior Director, Regulatory Affairs, Advertising, Promotion & Labeling, the Director, Regulatory Affairs, Advertising and Promotion will be responsible for providing sound regulatory advice related to communication of information related to assigned Alkermes products and disease areas.
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Sr. Director, Clinical Regulatory Affairs, Auto-Immune 2024363. Regulatory Affairs Certification (RAC) a plus. Expertise in regulatory submission structure and content, including IND, CTA, MAA, NDA, BLA, and extensive knowledge of regulatory guidelines of FDA, ICH, EMA, EU NCAs, MHRA, and other international regulatory agencies.
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The company is hiring a Vice President of Quality and Regulatory Affairs lead and develop the regulatory and quality strategy as well as play a key role in the execution of said strategy.
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The Regulatory Affairs Director (RAD) provides strategic and operational regulatory leadership to the development, commercialization and life cycle management of assigned oncology products.
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JOB DESCRIPTION Job TitleSr. Regulatory Affairs ManagerJob DescriptionSenior Regulatory Affairs Manager (U.S. Hub based location)The Senior Regulatory Affairs Manager will develop and communicate a vision for the RA function to management, including the development of global regulatory strategy in the area of regulatory submissions.
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Reporting to the SVP, Global Regulatory Affairs, the Senior Director will be responsible for developing and implementing global regulatory strategy leading to successful registration and life-cycle management of unique products serving patients with unmet medical needs.
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The Manager, Regulatory Affairs provides regulatory support for oncology products in early- and late-stage development. Draft and/or modify applicable SOPs and/or other written practices relating to the regulatory affairs function.
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Author and sign Regulatory Determinations on worldwide registration impact for significant product modifications as a design output. Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
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Qualifications 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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Location:The Director, Global Regulatory Affairs - Oncology role is flexible, including remote work arrangement within the US. The Director, Global Regulatory Affairs – Oncology is responsible for the global regulatory strategy and execution for assigned projects in the oncology pipeline.
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This is a Heavy Data Migration role, candidates should have Knowledge of Regulatory, Publishing, or EDMS models. Regulatory and/or Parexel Insight Manager knowledge a plus. This is a Heavy Data Migration role, candidates should have Knowledge of Regulatory, Publishing, or EDMS models.
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regulatory affairs jobs Title: regulatory affairs in Burlington, MA
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