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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...Description
We're looking for an Associate Director of Regulatory Affairs , working in Pharmaceuticals and Medical Products... ...other departments at various levels and with CROs and external consultants
Confident and has the professional competence to win respect...
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Flexible hours
...have you in front of a live recruiter.
The Opportunity
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...
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The Associate Director of Regulatory Affairs CMC will be responsible for developing, implementing and advising on global Regulatory CMC strategies for new and late stage programs to secure approval of the manufacturing process and control testing for initial clinical trials...
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...The Principal Regulatory Affairs Specialist will play a critical role in ensuring our Coronary Vascular products are safe, reliable, and compliant with global regulatory standards through team leadership and providing regulatory guidance for Sustaining and New Product...
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Local area
Worldwide
Work visa
...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
...anchored around deep expertise in immunology and complemented by an expanding set of capabilities.
Associate Director, Global Regulatory Affairs, CMC Authoring (Remote)
You will author global quality regulatory documents and provide input into development of...
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Remote job
Hourly pay
Holiday work
Worldwide
...Job Description
Manager, Global Regulatory Affairs
About This Role
The Global Regulatory Affairs Manager, works closely with Global and Regional Regulatory Leads providing support for a variety of regulatory activities for development and marketed products...
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Full time
Local area
...Job Description
Manager, Regulatory Affairs
About This Role
The Manager, Regulatory Affairs, works closely with the US Regulatory Lead and participates on cross-functional project teams and present the US regulatory position to senior management governance...
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Full time
Local area
...Exciting opportunity for a Full Time Senior Vice President, Regulatory Affairs and Quality to lead regulatory strategy and quality systems for cutting-edge biotech projects at Beacon Therapeutics. As a pivotal member of our team, you will have work from home flexibility...
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Full time
Remote job
Work from home
Flexible hours
...Job title: Regulatory Strategist (RS)
Report to: Global Regulatory Lead (Anu Mahashabde)
Knowledge, Skills & Competencies:
Proactively... ...experience, including at least 4 years of relevant Regulatory Affairs experience (regionally and/or global) especially in...
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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
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...
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Local area
Remote job
Worldwide
Relocation
Work visa
...Associate Director Global Regulatory Affairs CMC
Through your innovation, passion and unity with your colleagues you can become a pioneer in our Global Regulatory Affairs Team.
In this position, you will lead all aspects of Global Regulatory Affairs CMC...
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Flexible hours
Data Scientist, Clinical & Regulatory Data Scientist, Clinical &
Regulatory Cambridge, MA, ModernaTX, Inc. Req: Masters in Bio, Bioinformatics, Stats or rltd fld + 4 yrs exp as data sci, bus anlyst or rltd positn in machine learng. May telecommute up to 3 days/wk. Email...
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...Associate Director , US Advertising and Promotion , Global Regulatory Affairs - Hybrid
LOCATIONS: this is a hybrid role based in either... ...- and long-term business objectives while mitigating risk. Consults with senior management and provides input to the global organization...
Temporary work
...Senior Manager, Global Regulatory Affairs - US Strategy
Your responsibilities may include:
~ Advise on US FDA procedures... ...with collaborators or external partners such as regulatory consultants, contract research organizations (CRO) and 3rd parties preferred...
Hourly pay
Holiday work
Contract work
Work experience placement
...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
Gradient, 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...
Temporary work
...purpose, and passion.
The Role
The Vice President, Medical Affairs will build and lead the medical affairs team and work cross-... ...Facilitate key processes including medical-legal-regulatory review, grant review, and investigator-initiated study (IIS) review...
Local area
Immediate start
...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
...Responsibilities
The Associate Director RA serves as the regulatory lead on Review Committees (RCs). As the RC RA representative,... ...expected to competently and confidently represent Regulatory Affairs as a key member of cross-functional RC teams for assigned, as...
Remote job
...Vice President, Head of Medical Affairs
About the Company
Dynamic biotech company... ...with business strategies and legal and regulatory guidelines, and leading key sub-... ...managing a mix of direct reports and external consultants and vendors, and have experience...
...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...
...Medical Officer, the VP, Head of Medical Affairs will build and lead this function at... ...to-be-hired direct reports and external consultants and vendors. The ideal candidate will have... ...with business strategies and legal and regulatory guidelines.
Collaborate with cross-...
Local area
...Senior Manager, Regulatory Project Management - Contract - Cambridge, MA
Proclinical is seeking a Sr. Manager, Regulatory Project Manager for a leading pharmaceutical company. This is a contract position located in Cambridge, MA.
Primary Responsibilities:
The...
Contract work
...Technical Consultant
As a technical consultant you will work directly with customers and Philips implementation team to deliver the platforms and application for the analytics suite called PerformanceBridge. Continue to impact customer adoptions of the software by...
Local area
Work visa
...some coverage needs during the next 3 months. This entry level role will provide critical support to leaders and employees within Regulatory. A high degree of initiative, self-direction and collaboration is required. The role requires a high degree of tact and...
Contract work
...America's leading retail pharmacy with more than 9,000 stores and continuing to grow. We seek a talented, sales-oriented Beauty Sales Consultant who is passionate about the retail beauty industry and believes the client experience should be top-notch. Our customers will...
Hourly pay
Holiday work
Full time
Temporary work
Local area
Flexible hours
Day shift
Afternoon shift
Long Term Contract
Pay Range: $52-62/hour
The Change management consultant we are looking for is a Change management professional, who is an expert in the people side of change within business transformations and large-scale global programs.
Role Profile...
Contract work