Takeda Development Center Americas, Inc. is seeking a Manager, Regulatory Affairs
CMC in Cambridge, MA to Develop the Global Regulatory Strategy for products in commercial and development phase; ensure timely submission of new submissions (IND, NDA, BLA, JNDA) to various...
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...in drug discovery, oncology drug development, and company building.
The Role:
Reporting to the Vice President, Global Regulatory Affairs, the Director of Global Regulatory Affairs will be responsible for driving and implementing worldwide regulatory strategies and...
Suggested
Work experience placement
Local area
Worldwide
Flexible hours
...urgency, purpose, and passion.
The Role
Reporting to the Chief Development Operations Officer, the Executive Director, Regulatory Affairs will lead the Regulatory Affairs function and drive development and execution of regulatory strategies for THRD products. This...
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Immediate start
...Together, we are leading the way towards a healthier and more equitable future.
Position Summary
As the Senior Manager of Regulatory Affairs, you will play a critical role in ensuring regulatory compliance and supporting the execution of our regulatory strategy for...
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Flexible hours
...vivo tumor models attributed to a distinct mechanism of action from existing cancer immunotherapies.
Role: Senior Director, Regulatory Affairs and Strategy
Purpose of the role:
Reporting to the Chief Development Officer, this team member will play a key...
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Holiday work
Full time
Temporary work
Remote job
Flexible hours
...Description
We're looking for a Manager of Regulatory Affairs , working in Biotechnology/Medical Devices industry in Cambridge, Massachusetts, United States .
Works with Regulatory Affairs management to define regulatory strategy and to compile and submit...
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...Title:
Director, Global Regulatory Affairs, Oncology
Company:
Ipsen Bioscience, Inc.
Job Description:
Director, Global Regulatory Affairs, Oncology
Summary / purpose of the position
To be accountable for the strategy, tactics and implementation of...
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Temporary work
Local area
Worldwide
Flexible hours
...tunable. Sail was founded by Flagship Pioneering.
The Role:
Reporting to the Chief Medical Officer, the Senior Director of Regulatory Affairs will be responsible for the development and execution of Sails regulatory strategy and operations. This person will lead the...
Suggested
Local area
...Description
We're looking for an Associate Director of Regulatory Affairs , working in Pharmaceuticals and Medical Products industry in Cambridge, Massachusetts, United States .
Works proactively in a cross-functional organization to partner with various...
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If you are internal-customer driven and have the desire to provide exceptional quality to a dynamic organization, then we would like to hear from you!
We are currently seeking an experienced Machine Operator to join our team on second shift, which runs from 3:30 PM to...
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For contractors
Local area
Visa sponsorship
Afternoon shift
Monday to Friday
...U.S. Advertising and Promotion (USAP) will provide strategic regulatory advice to internal stakeholders regarding tactics and communications... ...•Collaborate with colleagues in Commercial, Medical Affairs, Legal, Compliance and other expertise areas in creation of promotional...
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Flexible hours
Are you a seasoned Senior Regulatory Leader looking for a new and exciting challenge? Beacon Therapeutics (USA) Inc is seeking a talented... ...a Full Time Senior Vice President, Head of Global Regulatory Affairs, completely remote! In this role, you will have the...
Suggested
Full time
Remote job
Flexible hours
...Description
We're looking for an Associate Director Regulatory Affairs CMC , working in Pharmaceuticals and Medical Products industry in Cambridge, Massachusetts, United States .
Leads development and execution of robust global regulatory CMC strategy for...
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...Vice President, Head of Medical Affairs
About the Company
Dynamic biotechnology (BioTech... ...with business strategies and legal and regulatory guidelines, and leading key sub-functions... ...a corporate governance structure.
The VP, Head of Medical Affairs will be expected...
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JOB DESCRIPTION
Job Title
Senior Regulatory Affairs Specialist
Job Description
Senior Regulatory Affairs Specialist (U.S. Hub based location)
The Senior Regulatory Affairs Specialist is responsible for regulatory compliance, strategy and submissions...
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Remote job
Worldwide
Relocation
Work visa
...Associate Director, Global Regulatory Affairs, CMC Authoring
You will author global quality regulatory documents and provide input into development of regulatory CMC strategy for the assigned projects (e.g., iNeST) in different stages of development, including...
Hourly pay
Holiday work
...Responsibilities
Global Regulatory Affairs Lead (GRL)
Mission statements
The Global Regulatory Affairs Lead (GRL) is the fully accountable decision maker for the development & execution of creative, thoughtful, and robust global regulatory strategies for their...
JOB DESCRIPTION
Job Title
Principal Regulatory Affairs Specialist
Job Description
Principal Regulatory Affairs Specialist (U.S. Hub based)
Clinical Integration and Insight (CII) is changing the way healthcare is delivered at the point of care. Our...
Local area
Remote job
Worldwide
Relocation
Work visa
...Senior Manager, Global Regulatory Affairs - US Strategy
Your responsibilities may include:
~ Advise on US FDA procedures, requirements and administrative documentation
~ Establish and maintain transparent and collaborative relationship with the Agency...
Hourly pay
Holiday work
Contract work
Work experience placement
...Position Overview:
VP/SVP, of Medical Affairs will be responsible for designing Medical Affairs strategy and building out the Medical Affairs... ...to internal (Commercial, Manufacturing, Market Access, Regulatory, R&D, and Legal) and external (healthcare professionals, patients...
Local area
...transform hope into reality?
The Medical Director, Medical Affairs will be responsible for development and execution of the Ayvakit... ...committees.
Collaborate internally with clinical and regulatory departments to support the planning, execution, and management...
Home office
Gangs
...an environmental consulting firm, is seeking a high-energy individual to assist colleagues and clients by applying knowledge of regulatory toxicology and chemistry to projects involving chemical compliance, product stewardship, and green chemistry-based alternatives assessments...
Temporary work
...education: Bachelors
responsibilities:
Provides regulatory expertise and guidance to Clinical, Pharmacovigilance, Legal,... ...to support labeling documentation
skills: Regulatory Affairs Operations
Equal Opportunity Employer: Race, Color,...
Hourly pay
Contract work
Work experience placement
Remote job
...Responsibilities
About the Role
The Associate Director, US Regulatory Affairs (RA) serves as the regulatory lead on relative Review Committees (RCs), for products in the Rare Disease, Rare Blood Disorder and Neurology portfolio. As the RC RA representative, work...
Temporary work
Remote job
...transform hope into reality?
The Senior Director, Corporate Legal Affairs will use their understanding of securities law and corporate... ...business and protects the companys interests. Reporting to the VP, Corporate Legal Affairs, you will have the opportunity to directly...
Gangs
...opportunities to streamline processes, reduce lead times, and enhance overall supply chain efficiency while maintaining compliance with regulatory requirements.
Manage operating budget and allocate resources to optimize business results.
Direct activities related to...
For contractors
...marketing applications, agency briefing packages and response to regulatory authority queries. The Director will incorporate regulatory... ...responsible for:
Provide CMC expertise in the Editas regulatory affairs organization by keeping abreast of global CMC regulatory...
Flexible hours
...The Role:
Reporting to the Chief Medical Officer, the VP, Head of Medical Affairs will build and lead this function at Nuvalent. This person... ...are aligned with business strategies and legal and regulatory guidelines.
Collaborate with cross-functional teams to...
Local area
...together.
Job Description
The Head of Global Medical Affairs will provide strategic leadership to develop an integrated... ...across Bicycle including, but not limited to: Research, Clinical, Regulatory Affairs, Commercial, and other functions, to ensure that...
Holiday work
Immediate start
Flexible hours
...with us if you are looking to be a part of creating hope for a healthy future in many people's lives.
Senior Director, Global Regulatory Affairs Development Pipeline, Cell Therapy
Primary responsibilities include:
#Act as global regulatory lead for assigned...