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$133.2k - $223.2k
...Development Center Americas, Inc. is seeking a Manager, Global Regulatory Affairs CMC in Cambridge, MA with the following requirements: Master’... ...the response to health authority queries are provided in a timely and efficient manner by working with regulatory teams across...
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Full time
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$138.5k - $186k
...Development Center Americas, Inc. is seeking a Manager, Global Regulatory Affairs CMC Submissions Management in Lexington, MA with the... ...domestic travel required. Up to 50% remote work allowed.
Full time. $138,500 - $186,000 per year.
Apply on-line at and search...
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Worldwide
...Responsibilities:
Interpret regulatory filings and lead cross-functional teams to comply with new or revised regulations.
Cultivate... ...and with external stakeholders. Partner with Corporate Affairs, Rate Engineering, Law, Customer Energy Solutions, Corporate Accounting...
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Flexible hours
...participation on design and risk management teams, initiation of regulatory plans for both new products and significant product... ...for new products and significant post-market modifications as part of design input.
Author and sign Regulatory Determinations on...
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Worldwide
...building.
The Role:
Reporting to the Vice President, Global Regulatory Affairs, the Director of Global Regulatory Affairs will be... ...Develop and drive regulatory strategy and plans for quality and timely submissions.
Provide regulatory guidance regarding FDA and...
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Work experience placement
Local area
Worldwide
Flexible hours
...disease.
Description:
Reporting to the Sr. Director of Regulatory Affairs and Policy, this role will support and lead activities within... ...collaborate with the relevant subject matter experts to ensure timely execution of regulatory milestones.
Promptly identify...
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Local area
Remote job
...different viewpoints and skill sets to be a part of a productive and inclusive team.... ...products while maintaining compliance with all regulatory requirements and commitments. Evaluates... ...good safety practices at all times including appropriate use of protective equipment...
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Contract work
Local area
Night shift
...equitable future.
Position Summary
As the Senior Manager of Regulatory Affairs, you will play a critical role in ensuring regulatory... ...Reports, Orphan Drug Designation Annual Reports, etc.) to ensure timely submission to regulatory authorities.
Regulatory...
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Flexible hours
...About the Job
The Regulatory Affairs (RA) Director is responsible for the development and implementation of a comprehensive global regulatory strategy that supports the evolution and enhancement of FMI's unparalleled global portfolio of assay products, including...
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Work experience placement
...worldwide.
Join Takeda as a Director, Regulatory Affairs Vaccines CMC where you will provide... ...necessary, directly and indirectly. As part of the RAV CMC team, you will report to... ...and communicating in a professional and timely manner
Stay abreast of current and evolving...
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...Vice President, Regulatory Affairs and Quality
Xilio Therapeutics is a clinical-stage biotechnology company discovering and developing tumor... ...sound judgement and communicating in a professional and timely manner. Anticipates and manages risks.
Monitors and anticipates...
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For contractors
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...Hybrid Role
The Associate Director of Regulatory Affairs CMC will support development CMC team activities for an emerging portfolio of biologics... ....
Responsibilities:
Ensures high-quality and on-time submissions, including for INDs, IMPDs, CTAs and BLAs, that align...
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...Description
Position Summary:
Reporting to the Senior Director, Regulatory Affairs, Advertising, Promotion & Labeling, the Director, Regulatory... ...as primary contact for OPDP for assigned products and ensure timely and accurate submission of product promotional materials to...
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...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
...Title:
Director, Global Regulatory Affairs, Oncology
Company:
Ipsen Bioscience, Inc.
Job Description:
Director, Global Regulatory... ...profile, taking into consideration the most favorable timing for all key markets.
Continuously evaluate the global match...
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Flexible hours
...Vice President, Regulatory Affairs
About the Company
Clinical-stage biotechnology (BioTech) company developing treatments for rare-diseases
Industry
Biotechnology
Type
Public Company
Founded
2010
Employees
501-1000
Categories
Biotechnology...
...Vice President of Regulatory Affairs
About the Company
Leading biopharmaceutical firm specializing in oncology therapeutics
Industry
Biotechnology
Type
Public Company
Founded
2014
Employees
11-50
Funding
$101-$200 million
Categories...
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Vice President Regulatory Affairs
Vice President Regulatory Affairs
JOB_52123511161109... ...VP, Head of Regulatory Affairs in the Boston Area.
- Full time Role
- Role in the Boston Area. (Open to discuss if it's East...
Permanent employment
Full time
...Job Description
Job Description Principal Regulatory Affairs Specialist
Job DescriptionBrioHealth Solutions Inc., Inc. is seeking a skilled and self-motivated Principal Regulatory Affairs Specialist to join our growing team. As a principal regulatory affairs...
...details on our portfolio.
Job Description
The Manager, Regulatory Affairs provides regulatory support for oncology products in early-... ...includes but is not limited to the following:
~ Non-accrual paid time off
~ Summer vacation bonus
~ Global, company-wide summer...
Temporary work
Summer work
Summer holiday
Flexible hours
