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...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...
Suggested
Full time
...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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Summer work
Local area
Day shift
...Support the implementation of Veeva Vault, IDMP, EU CTR, and other regulatory initiatives.
Work with stakeholders to gather requirements... ...scope of assigned products/franchises at the discretion of Director. Leads cross-functional teams in the development and...
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Work experience placement
Remote job
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...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
...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
...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
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...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...
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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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...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
...Forbes .
About the Role
As SIRUM’s first Legislative Affairs Director, you’ll lead SIRUM’s policy efforts across the country and... ...provide technical feedback and expertise for all legislative and regulatory efforts. You’ll play a key role in stopping medications from...
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Remote job
Holiday work
Full time
Flexible hours
...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
$250k - $300k
....
To learn more about our story and company culture, visit us at | Who You Are
Reporting to CMO Doug Sproule, the Director, Medical Affairs will be responsible for developing and executing the Medical Affairs strategy and serving as a strategic partner in the business...
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Flexible hours
Weekend work
...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
...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...
Remote job
...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...
Temporary work
Local area
...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
...information.
About the role:
We are looking for a forward-thinking, charismatic, and dynamic cardiologist to serve as Senior Director, Medical Affairs. A key team member of the organization, this role will serve as an expert in meetings/speaking events, review member-...
Remote job
Work experience placement
Easy work
...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