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12

Fda Regulatory Subject Matter Expert Jobs






Job info
 
Company
**********
Location
Princeton, NJ
Posted Date
Jun 13, 2020
Info Source
Employer  - Full-Time  90  

... processes to determine compliance with regulatory requirements, guidelines and established standard ... an emphasis on technical expertise, regulatory risk, and quality advice. GQ-QLP ... also responsible or coordination/management of..

 
Company
**********
Location
Summit, NJ
Posted Date
Jul 25, 2020
Info Source
Employer  - Full-Time  90  

... activities to ensure patient safety, regulatory requirements and improve its effectiveness ... Product Deviation Reports for the FDA or the equivalent notifications to ... Thorough understanding of cGMPs and..

 
Company
**********
Location
Minneapolis, MN
Posted Date
Feb 25, 2022
Info Source
Employer  - Full-Time  90  

... BiFi and Peperami.Job DescriptionThe Sr. Regulatory Affairs Specialist is responsible for ... interpret labeling regulations and communicate regulatory, labeling and compliance matters. Responsible ... government interactions pertaining to the..

 
Company
**********
Location
,
Posted Date
Mar 05, 2023
Info Source
Employer  - Full-Time  90  

... stakeholders. Serve as a cGMP consultant/subject matter expert, providing researched and fact-supported information ... including assessing whether response meets regulatory authority, local authority, and BioMarin ... with GxP Strategy..

 
Company
**********
Location
Pearl River, NY
Posted Date
Mar 02, 2022
Info Source
Employer  - Full-Time  90  

... will ensure compliance with global regulatory requirements, maintain/improve data quality, and ... from appropriate departments, functions, and Subject Matter Experts (SMEs) regarding information needed ... assurance, compliance, data management,..

 
Company
**********
Location
Monmouth Junction, NJ
Posted Date
Mar 04, 2022
Info Source
Employer  - Full-Time  90  

... (cGMPs), Food and Drug Administration (FDA) standards, relevant foreign drug regulatory standards, established specifications, and drug ... purview. She/he is recognized as subject matter expert in the principles and..

 
Company
**********
Location
Northridge, CA
Posted Date
Mar 01, 2022
Info Source
Employer  - Full-Time  90  

PRINCIPAL REGULATORY AFFAIRS SPECIALIST - CYBERSECURITY Transforming ... exciting role as a Principal Regulatory Affairs Specialist in Cybersecurity, you ... will develop and implement medical regulatory strategies to obtain timely..

 
Company
**********
Location
Boulder, CO
Posted Date
Mar 02, 2022
Info Source
Employer  - Full-Time  90  

... compliant with all relevant regulations (FDA, 13485, PMDA). Provide feedback to ... assessments to ensure quality and regulatory requirements are successfully implemented and ... and regulations and ensures that..

 
Company
**********
Location
Philadelphia, PA
Posted Date
Oct 12, 2022
Info Source
Employer  - Full-Time  90  

... in quality;• Acts as a subject matter expert (SME) on quality compliance in ... support of corporate and plant FDA inspections and sit in with ... inspections and sit..

 
Company
**********
Location
,
Posted Date
Mar 30, 2023
Info Source
Employer  - Full-Time  90  

Job Description:Title: Sr. Audit Manager - Good Pharmacovigilance Practices (GVP) / Drug Safety Location: Remote Travel: Up to 40% domestic and internationalu00A0About BioMarinu00A0BioMarin is a leading biopharmaceutical company with over 25 ..

 
Company
**********
Location
Waltham, MA
Posted Date
Apr 26, 2023
Info Source
Employer  - Full-Time  90 

PURPOSE AND SCOPE:The Senior Ethics & Compliance Officer (SECO) will manage the compliance program for several product lines within the renal pharmaceutical and medical device divisions of Fresenius Medical Care North ..

 
Company
**********
Location
San Rafael, CA
Posted Date
Sep 07, 2022
Info Source
Employer  - Full-Time  90  

... the Food & Drug Administration (FDA). The successful candidate may also ... the eGrants tool and the subject matter expert on BioMarinu2019s grants policies; Performing ... and promotional documents..

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