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...region of North America (US/CAN), provides regulatory guidance and advice on regulatory... ...strategies to introduce new products to market. Manages notifications and submissions to... ...Assists with the training of regulatory affairs personnel and provides direction on specific...
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...The Regulatory Affairs Specialist will be the regulatory representative for assigned due diligences, under the direction of the Global Regulatory... ..., from pre-clinical development through life cycle management.
Responsible for developing and maintaining an in-depth...
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...LMI is seeking an experienced Regulatory Affairs Manager to support our Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear (JPEO-CBRND) Regulatory Affairs and Quality Assurance (RAQA) client at our Ft. Detrick, MD location. Will serve as...
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Full time
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Flexible hours
...background not just lab but manufacturing and process development.
This manager position within CMC will facilitate product development and global registration by developing and executing regulatory strategies and effective regulatory agency interactions for product...
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Flexible hours
...Responsibilities arrow_right
Provide regulatory excellence to the organization and guide decision making
Responsible to direct, coordinate and supervise activities of Regulatory Affairs staff. Establish project priorities, ensure resources are available and balanced...
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Work from home
Home office
...Description:
Note:
This will be a 100% remote role
The hiring manager confirmed they are looking for someone who works regular hours... ...the implementation of Veeva Vault, IDMP, EU CTR, and other regulatory initiatives.
Work with stakeholders to gather requirements...
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Work experience placement
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Shift work
...participating in cross-functional teams responsible for the development and life cycle management of combination products/devices. The candidate utilizes expertise to provide Regulatory CMC global regulatory strategy, support development activities and execute...
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Part time
Shift work
Day shift
...-provided short-term disability, an employee assistance program, and a wellness program.
Position Overview:
The Counsel – Regulatory Affairs is responsible for supporting compliance with federal and state laws and regulations. Counsel – Regulatory Affairs will be expected...
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Temporary work
Local area
...Months
Summary Description
# Independently provide EU regulatory requirements and guidance to EU MDR project teams.
#... ...Received
~ Under minimal supervision of Sr. Manager or Director of Regulatory Affairs
Supervision Exercised
~ None
Essential Duties...
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Day shift
...Job Title: Sr. Regulatory Affairs Consultants
Location: (100% remote)
Duration: Long Term
Job Description:
Facilitate... ...regulatory requirements are met throughout the product lifecycle.
Manage regulatory submissions and approvals for oxygen concentrators...
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...in working at one of the World’s Best Workplaces, apply now !
Need another reason to apply? Here are 10 reasons to join our Regulatory Affairs/Quality Assurance team :
We are proud to be named one of the World’s Best Workplaces and a Best Workplace for Diversity...
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Local area
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Flexible hours
...work EST time if not on East Coast)
Performs eCTD submission management product portfolio to global Health Authorities for both major... ...assigned products.
* Acts as the primary point of contact for regulatory functions as appropriate in the products lifecycle. Partners...
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Shift work
...Responsible for leading and developing global regulatory strategy for assigned development... ...company as needed.
Responsibilities
Manages, directs, and drives the strategy for... ...5 years of experience within Regulatory Affairs
~ Knowledge of IND, NDA/BLA submission...
Suggested
Full time
...TECHNICAL SKILLS
Must Have
~ Advertising and Promotional Regulatory Assessment experience, change control, and US/EU submission experience... ...in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve...
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..., an employee assistance program, and a wellness program.
Position Overview:
The EVP, Regulatory Affairs Counsel is responsible for ensuring that company’s compliance management program comports with federal and state law. This role will provide leadership and direction...
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Temporary work
Local area
...with HFX Cloud™ insights for enhanced patient and practice management.
Nevro also recently added a minimally invasive treatment... ....
(Must live in the SF Bay Area)
The Principal Regulatory Affairs Specialist will be part of this high-performance team and responsible...
Full time
Temporary work
Relief
Worldwide
Night shift
...Description:
Note:
FULLY REMOTE
Job Details:
The Associate Regulatory Affairs (CMC) role is an entry level regulatory position that... ...phases of development.
Support may include organizing, managing and executing on regulatory CMC projects in support of regulatory...
Remote job
...submission and approval of CTA filings.
Reporting to our SVP, Regulatory Affairs, you will positively impact patients’ when you:
Plan,... ...to ensure execution excellence of all CTAs
Oversee and manage all CRO contributions to Karyopharm’s CTAs and escalate...
Holiday work
Full time
Work experience placement
Immediate start
$75k - $80k
...If you are a remote Regulatory Affairs Specialist with strong electrical and other engineering product standards to help put together our... ...Device Manufacturer with the first FDA approved non-toxic pain management system that offers a critical alternative to the Opioid...
Full time
Relief
Immediate start
Remote job
...data protection.
We are seeking an experienced Quality & Regulatory Compliance Manager to advance our compliance team's mission of ensuring that... ...four (4) years of professional experience in regulatory affairs or in quality management systems relating to medical devices...
Remote job
Full time
Worldwide
