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...the business, from drug development to marketing.
The Manager, Regulatory Affairs will be responsible for supporting and developing global regulatory... ...with departments outside of regulatory affairs and external to the company.
+ Maintains knowledge of highly complex...
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...+ Advise internal cross-functional team who may contribute to regulated communication on Regulatory/FDA issues including Public Affairs, Clinical Development, Legal, & others such as Commercial. Interpret FDA/European Medicines Agency (EMA) regulations, guidelines, policy...
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Join our dynamic Regulatory Affairs team as a Director, Regulatory Affairs,... ...success, working closely with internal and external stakeholders to ensure our projects meet... ...information
Influences Senior Management decisions through persuasive arguments...
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...on behalf of the supervisor, department manager, or chair in regards to establishing priorities... ...School of Medicine (SoM) Fiscal Affairs Group is to provide innovative services... ...University leaders, faculty, staff, and external stakeholders at the highest levels of the...
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...SUMMARY/JOB PURPOSE:
Responsible for managing and maintaining existing investigational new drug (IND) and clinical trial application... ...timelines in collaboration with Regulatory Operations and Regulatory Affairs staff to effectively enable a robust regulatory submissions...
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...metagenomic sequencing for diagnosis and management of infectious diseases and other diverse... ...experienced Vice President for Clinical Affairs to lead our clinical operations and... ...vendors, and collaborating with internal and external stakeholders.
Why Should You Join Us?...
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Regulatory Affairs Associate
Contract: Alameda, California, US
Salary: $55.0... ...Job Description:
Job Roles & Responsibilities:
Manager more interested in experience with years of exp.
Education...
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...pipeline by working across the Medical Affairs sub-functions, including the Medical Communications... ...and analyze data from relevant internal/external sources and provide insights to Medical... ...projects and/or functions.
Leads or manages the work of others by providing guidance...
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...The Vice President of CMC Regulatory Affairs is leading the Ultragenyx's CMC Regulatory... ...working with internal stakeholders and external partners to evaluate and enable gene therapy... ...activity and open positions are managed strictly through our Human Resources Department...
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...website at .
Executive Director/ Sr. Director of Medical Affairs
Overview
As a key member of Adicet's medical team,... ...Coordinate medical communication activities internally and externally.
Essential requirements:
MD, PhD, or PharmD. MD/PhD a...
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...innovative and highly motivated Principal Scientist, Scientific Affairs who will contribute significantly to the development and... ...of the company (with Business Development, Marketing, Product Management, Engineering and Process Sciences teams) to develop the best solutions...
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...information, visit
The Role:
As the Head of Business Legal Affairs at EVERY, you will be instrumental in shaping the legal... ...initiatives. Additionally, you'll oversee our commercial paralegal management. The role offers the prospect of leading other legal domains...
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...hiring a Director/Sr. Director, Regulatory Affairs, Therapeutics, to lead the regulatory... ...Director will oversee and partner with several external consultants in the short term. In the... ...KEY RESPONSIBILITIES
Lead, define and manage the strategic regulatory direction for Mammoth...
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...muscle function and contractility.
As the Director of Regulatory Affairs, Advertising and Promotion, you will report directly to the... ...Builds and maintains relationships across functions and with external partners, including regulatory health authorities, to achieve regulatory...
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...regulatory authorities
+ Prepares and/or manages submissions that are technically complex... ...with departments outside of regulatory affairs
+ Must be willing to provide hands-on,... ...note to recruiters:
We do not allow external search party solicitation. Presentation...
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...The Senior Director of Regulatory Affairs provides regulatory leadership and develops... ...correspondence and other records of interaction
Manages all maintenance plans for regulatory... ...Develop relationships with external partners
Monitors, analyzes, and disseminates...
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...with a strong background in _In Vitro_ Pharmacology to join the External Quantitative Biosciences group (ExQB).
Under the broad... ...Division's disease areas, as well as participate in relationship management of Contract Research Organizations (CRO). The ideal candidate...
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3 days per week
...customers.
Experience:
With 5-8 years of experience, you possess deep professional know-how and experience in regulatory affairs.
Candidates have a mastery of regulatory guidance documents and requirements for FDA 510(k) submissions, Health license applications...
...and Australia. For more information, please visit Gilead.com.
We have an exciting opportunity within our US Medical Affairs team for a Senior Manager, Medical Affairs Strategy within Liver Disease. This role will be in-house based in Foster City.
Senior Manager,...
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...Overview :
TekWissen Group is a workforce management provider throughout the USA and many... ...and Sovaldi.
Position: Medical Affairs Director
Location: Foster City, CA, 9... ...insights systematically, both internal and external, and translate these insights into actionable...
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