Search Results: 4,540 vacancies
...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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Local area
...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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Contract work
...-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
...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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Remote job
...Responsible for leading and developing global regulatory strategy for assigned development... .... Also communicates with outside consultants (i.e. CRO's) as needed.
Qualifications... ...years of experience within Regulatory Affairs
~ Knowledge of IND, NDA/BLA submission...
Suggested
Full time
...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
...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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Holiday work
Temporary work
Local area
Remote job
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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Shift work
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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Remote job
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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Remote job
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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Contract work
Immediate start
...program, and a wellness program.
Position Overview:
The EVP, Regulatory Affairs Counsel is responsible for ensuring that company’s... ...implement compliance initiatives in response to changes in the law; consults with various representatives, both internal and external, as...
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Temporary work
Local area
...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
...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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Remote job
...cross-functional alignment and on-time / right-first-time submission and approval of CTA filings.
Reporting to our SVP, Regulatory Affairs, you will positively impact patients’ when you:
Plan, execute and oversee all ex-US/ex-Canada CTA submissions in alignment...
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Holiday work
Full time
Work experience placement
Immediate start
...patient needs in order to improve outcomes and quality of life for patients.
(Must live in the SF Bay Area)
The Principal Regulatory Affairs Specialist will be part of this high-performance team and responsible for developing regulatory strategies, preparing U.S....
Full time
Temporary work
Relief
Worldwide
Night shift
...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...
Shift work
$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
Remote job
...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...
Remote job
Full time
Temporary work
Work experience placement
Local area
Flexible hours
$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
Remote job
