Average salary: $96,127 /yearly
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...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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...region of North America (US/CAN), provides regulatory guidance and advice on regulatory... ...Assists with the training of regulatory affairs personnel and provides direction on specific... ...goals.
Represent EPC to trade association Committees or Task Forces as assigned....
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...The Regulatory Affairs Specialist will be the regulatory representative for assigned due diligences, under the direction of the Global Regulatory... ...In this case, you will identify and assess regulatory risks associated with product development and define strategies to mitigate...
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...and a wellness program.
Position Overview:
The Counsel – Regulatory Affairs is responsible for supporting compliance with federal and... ...Qualifications and Skills:
~Juris Doctorate (JD) from an American Bar Association (ABA) accredited law school.
~Minimum of 2 years in the...
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...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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...Description
# Independently provide EU regulatory requirements and guidance to EU MDR... ...of Sr. Manager or Director of Regulatory Affairs
Supervision Exercised
~ None... ...documentation.
Review change orders associated with the MDR project deliverables.
Writes...
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...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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...development and global registration by developing and executing regulatory strategies and effective regulatory agency interactions for... ...of experience OR Bachelor degree and 5 years of experience OR Associate degree and 10 years of experience OR High school diploma / GED...
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...Responsible for leading and developing global regulatory strategy for assigned development... ...strategy for all Regulatory activities associated with the registration and support of new... ...5 years of experience within Regulatory Affairs
~ Knowledge of IND, NDA/BLA submission...
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...Responsibilities arrow_right
Provide regulatory excellence to the organization and guide... ...and supervise activities of Regulatory Affairs staff. Establish project priorities, ensure... ...needed regulatory submissions and associated documents for FDA, Health Canada, MDR, Notified...
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...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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...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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...program, and a wellness program.
Position Overview:
The EVP, Regulatory Affairs Counsel is responsible for ensuring that company’s... ...testing, and monitoring, including root cause of issues and associated remediation.
~Evaluate and implement compliance technologies...
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...assigned products.
* Acts as the primary point of contact for regulatory functions as appropriate in the products lifecycle. Partners... ...sciences, and drives innovative process change for improved efficiency.
Education:
Associate Degree
Shift:
1st Shift M-F...
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...Regulatory Associate – Neurosurgery Department
Why UT Southwestern?
With over 75 years of excellence in Dallas-Fort Worth, Texas, UT Southwestern is committed to excellence, innovation, teamwork, and compassion. As a world-renowned medical and research center, we...
Full time
$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...
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Government Affairs Business Associate Location Remote in Washington, DC : We are seeking a highly motivated candidate to join our growing firm as a Government Affairs Business Associate . The ideal candidate will have excellent written and oral communication skills...
Full time
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...
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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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