Average salary: $108,005 /yearly
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...counter drugs for the region of North America (US/CAN), provides regulatory guidance and advice on regulatory requirements. Monitors... ...operating procedures. Assists with the training of regulatory affairs personnel and provides direction on specific projects. Assures...
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...The Regulatory Affairs Specialist will be the regulatory representative for assigned due diligences, under the direction of the Global Regulatory Strategy Lead (GRSL).
An external company and assets or individual assets alone can be the subject of due diligence....
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...-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
...Top 3 Must Have Skill Sets:
Familiarity with Global Clinical Trial Applications, Marketing Authorizations, Regulations, and Regulatory Guidance, including familiarity with US Certificate of Pharmaceutical Product (CPP) process.
Basic understanding of the Veeva...
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Immediate start
Remote job
Flexible hours
Shift work
...Job Title: Sr. Regulatory Affairs Consultants
Location: (100% remote)
Duration: Long Term
Job Description:
Facilitate regulatory submissions for CGM devices, ensuring compliance with relevant regulations and standards.
Stay updated with changes...
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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
...6+ Months
Summary Description
# Independently provide EU regulatory requirements and guidance to EU MDR project teams.
# Lead the... ...minimal supervision of Sr. Manager or Director of Regulatory Affairs
Supervision Exercised
~ None
Essential Duties And...
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Day shift
...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 manufacturing and quality programs throughout product...
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Flexible hours
...Summary
Responsible for leading and developing global regulatory strategy for assigned development projects. Represents Daiichi... ...experience including 5 years of experience within Regulatory Affairs
~ Knowledge of IND, NDA/BLA submission experience
~ Experience...
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Full time
...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
...TECHNICAL SKILLS
Must Have
~ Advertising and Promotional Regulatory Assessment experience, change control, and US/EU submission experience
Responsibilities may include the following and other duties may be assigned. Directs or performs coordination and preparation...
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Immediate start
...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 combination product submission deliverables.
This...
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Part time
Shift work
Day shift
...company-provided short-term disability, 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...
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Temporary work
Local area
...Description:
Note:
FULLY REMOTE
Job Details:
The Associate Regulatory Affairs (CMC) role is an entry level regulatory position that provides varying levels of product support to the regulatory Chemistry, Manufacturing and Controls (CMC) department, across regions...
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...basis to ensure successful execution of operational activities for assigned products.
* Acts as the primary point of contact for regulatory functions as appropriate in the products lifecycle. Partners with planning and tracking to ensure submission deliverables are...
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$75k - $80k
...If you are a remote Regulatory Affairs Specialist with strong electrical and other engineering product standards to help put together our EU MDR submissions - please read on!
Headquarters in beautiful Pompano Beach, FL (a stone's throw from the white sand & green water...
Full time
Relief
Immediate start
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$85k - $90k
...If you are a Sr Regulatory Affairs Specialist with strong medical device experience looking for a 100% Remote role you must read on!
Headquarters in beautiful Pompano Beach, FL (a stone's throw from the white sand & green water!) We are an innovative and first-of-it...
Full time
Relief
Immediate start
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...What Regulatory Affairs contributes to Cardinal Health
Regulatory provides regulatory affairs and product development consulting services to enable pharmaceutical, medical and biotechnology companies to obtain regulatory approvals. This function applies subject matter...
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Full time
Temporary work
Work experience placement
Local area
Flexible hours
...Job Description
Job Description TEHORA est présentement à la recherche d’un(e) Architecte d’affaires ayant d’excellentes aptitudes techniques, d’excellentes connaissances et qui souhaite mettre à profit ses compétences au sein d’une équipe polyvalente.
Sans être...
...and data protection.
We are seeking an experienced Quality & Regulatory Compliance Manager to advance our compliance team's mission of... ...least four (4) years of professional experience in regulatory affairs or in quality management systems relating to medical devices.....
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Full time
Worldwide