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Collabera
Alameda, CA, United States
Description Home Search Jobs Job Description Regulatory Affairs Associate Contract: Alameda, California, US Salary: $55.00 Per Hour Job Code: 335424 End Date: 2024-06-05 Days Left: 1 days, 3 hours left Apply To discuss more about this job opportunity, please reach out to Chitrank Rastogi (LinkedIn URL - https://www.linkedin.com/in/chitrank-
Job Source: CollaberaExelixis
Alameda, CA, United States
SUMMARY/JOB PURPOSE: Responsible for managing and maintaining existing investigational new drug (IND) and clinical trial application (CTA) submissions and preparing amendments in compliance with guidelines and regulations. Coordinates, compiles, and tracks product applications to regulatory agencies. Essential Duties And Responsibilities: Review cl
Job Source: ExelixisCollabera
Alameda, CA, United States
Description Home Search Jobs Job Description Regulatory Affairs Associate Contract: Alameda, California, US Salary: $55.00 Per Hour Job Code: 335424 End Date: 2024-04-10 Days Left: 26 days, 3 hours left Apply To discuss more about this job opportunity, please reach out to Chitrank Rastogi (LinkedIn URL - https://www.linkedin.com/in/chitrank-
Job Source: Collabera4D Molecular Therapeutics
Emeryville, CA, United States
Attention recruitment agencies: All agency inquiries are vetted through 4DMT's internal Talent Acquisition team. No unsolicited resumes will be accepted. Agencies must be expressly engaged by the 4DMT Talent Acquisition team on any requisition. Agencies reaching out directly to hiring managers will not be tolerated and doing so may impact your abi
Job Source: 4D Molecular TherapeuticsInnova Solutions
San Rafael, CA, United States
Innova Solutions is immediately hiring for an Associate Director, Regulatory Affairs Position type: Full time Contract Duration: 6 months Location: San Rafael, CA As a Associate Director, Regulatory Affairs , you will: Job Description: Regulatory Strategy Development Lead the development, integration, execution and maintenance of the glo
Job Source: Innova SolutionsThe Fountain Group
San Mateo, CA, United States
Overview: Prefers the candidate to be local in the Bay Area BUT will consider qualified candidates with Pharma Regulatory CMC experience in the Pacific time zone ONLY. Responsibilities Responsible for the preparation of moderately complex regulatory submissions which require interaction with departments outside of Regulatory Affairs CMC for invest
Job Source: The Fountain GroupAlector
South San Francisco, CA, United States
Our mission is to develop therapies that empower the immune system to combat neurodegeneration and our team is focused on developing treatments for some of the most challenging diseases facing our society. We are supported in this mission by experienced and accomplished scientists and clinicians, a novel portfolio of programs, leading healthcare in
Job Source: AlectorCytokinetics
South San Francisco, CA, United States
Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which cardiac muscle performance is compromised. As a leader in muscle biology and the mecha
Job Source: CytokineticsAlameda, CA, United States
Hello,
I Hope you are doing great.
This is Bhanu from Intellectt INC; we’ve got an important role Regulatory Affairs Associate - Alameda, CA with one of our prestigious clients. Interested candidates can please send your updated resume at [email protected]
Role: Regulatory Affairs Associate
Location: Alameda, CA
Duration: 12 Months
Shift Timings: 8 AM to 5 PM PST
Job Description
Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval.
Authoring and submitting PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports).
Review/approval of engineering study protocols/reports and validation study protocols/reports.
Review and approval of manufacturing changes for Class III implantable medical devices.
May require an advanced degree and 5-8 years of direct experience in the field.
Recent experience with Class III implantable medical devices;
Proven successful track record of authoring/submission/approval of Class III implantable PMA supplements;
knowledge of FDA PMA guidance documents and CFR regulations.
Relies on extensive experience and judgment to plan and accomplish goals.
Performs a variety of tasks.
May lead and direct the work of others.
A wide degree of creativity and latitude is expected.
Typically reports to a manager or head of a unit/department.
Thanks & Regards,
Ajay Bhanu
Intellectt Inc
Direct: 732 784 4384
Desk number : 732 412 6999- Ext: 159
517 Route 1 South, Suite 1115 Iselin, NJ 08830
WhatsApp: https://chatwith.io/s/bhanu
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Email Alert for Regulatory Affairs Associate jobs in Alameda, CA, United States
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