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Job Description
Takeda Development Center Americas, Inc. is seeking a Manager, Global Regulatory Affairs CMC in Cambridge, MA with the following requirements: Master’s degree in Regulatory Affairs or related field plus 2...
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...activities are growing rapidly, and we are currently seeking a full-time, office-based Regulatory Project Manager to join our Cincinnati team! This person will be a key member of Regulatory Affairs project teams to accomplish tasks that are instrumental to the company's...
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...Overview
Represents the Regulatory Affairs function in project teams, and manages regulatory projects to established timelines and budgets. Oversees and ensures compliance with state, federal and International medical device regulations and overall regulatory departmental...
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...information pertinent to the regulatory process, including the regulatory... ...electronic submissions
* Manage requests from foreign... ...regulatory direction to development project teams as a core team member;... ...relationships between Regulatory Affairs and other areas of the...
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...of growth!Job DescriptionThe Manager is responsible for the generation... ...to direct reports for projects assigned. Finally, candidate... ...submission requirements, legal, & regulatory requirements.
Perform in... ..., specifically in Regulatory Affairs & US NDA 505(b)(2) / ANDABe able...
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...advancement of eye health in the future.
Objectives:
The Regulatory Affairs Manager handles all regulatory development aspects of contact... ...are adequately supported by data.
Ability to assess project risks, and where appropriate, recommend contingency plans...
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...Pharmaceutical, Biotechnology or Biologics Regulatory Affairs
This individual will prepare, compile, and submit CT/IND/MAA I NOA, manage and implement label review, translation... ...Work closely with Supply Chain, Project Management, QA teams to identify process...
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...Manage and oversee all assigned projects/products/processes. Assist the Director/ Associate Director in assuring Novo Nordisk compliance with internal... ...and submission of any required documents to regu Regulatory Affairs, Manager, Regulatory, Manufacturing, Business...
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The Opportunity
The Regulatory Affairs Manager will work out of either our Plymouth, St. Paul or Maple Grove... ...units. May lead a cross-functional or cross-divisional project team. Provides technical leadership to business units. Acts...
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ADMA Biologics - Boca Raton, FL... ...opportunity available for a Manager, Regulatory Affairs in Boca Raton, FL !
The Manager,... ...Regulatory Affairs.
Performs other projects, project-based tasks and/or special projects...
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...InformationAt Thermo Fisher Scientific, the Regulatory Affairs function plays a vital role in ensuring... ...safer.Discover Impactful Work:As Sr. Manager, Regulatory Affairs, you will assume a... ...prioritize and manage multiple complex projects simultaneously. Possess the ability to...
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...purpose accelerates our mission. What you will doAs a Sr. Manager - Global Regulatory Affairs, you will be responsible for developing strategic global... ...management, process support, and participation in project teams. You will provide input and help influence global...
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...of the box thinking, cross-functional collaboration, and creativity.As a member of the regulatory team, the Sr. Manager, Regulatory Affairs has responsibility to work with project team members to identify and execute regulatory strategies to obtain commercial approval...
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...quality of life through the design and provision of device and management solutions for the treatment of structural heart disease.
**The Opportunity**
We are recruiting for a **Regulatory Affairs Project Manager** to join our team on-site in our St. Paul, MN...
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...uses for existing products that providea lasting benefit for growers.
Tessenderlo Kerley, Inc. is adding an additional Regulatory Affairs Manager to join their talented Regulatory team. As the newest Regulatory Affairs Manager, you will be responsible for registering...
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...Divya | (***) ***-****
Rashi | (***) ***-****
Title: Regulatory Affairs Project Leader
Location:Santa Clara, CA
Duration: 1... ...of regulatory strategy and priorities in conjunction with management, peers, commercial, and affiliate personnel.
Communicates...
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...related experience in a pharma regulatory-related role open all... ...matters related to policy, product/project strategy, FDA engagement, and... ...products and the life cycle management of products in the portfolio... ...with colleagues (R&D, External Affairs, etc.) leading policy activities...
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...work in our office three days per week on average.
The Manager of Regulatory Affairs (RA) Labeling will assist in the development of a cross-functional... ...management of senior professionals and higher- level project teams.
Ability to work in a cross-functional team...
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...oncology, as well as other research areas centered around rare diseases and immune disorders.
Summary
The Manager, Regulatory Affairs – Regulatory Project Management (RPM) provides planning and coordination supports for global and US regulatory activities. The Manager...
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...leader in new product development and medical education in orthopedics. Arthrex is actively searching for a Sr. Project Manager, Program Manager – Regulatory Affairs who is responsible for managing and resolving issues related to the time, budget, and resource allocation...
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