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Regulatory Affairs Associate
1 week ago
INTELLECTT INC Alameda, United StatesHello, · I Hope you are doing great. · This is Bhanu from Intellectt INC; weve got an important role Regulatory Affairs Associate -Alameda, CA with one of our prestigious clients. Interested candidates can please send your updated resume at · Role: Regulatory Affairs Associa ...
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Regulatory Affairs Associate
1 week ago
INTELLECTT INC Alameda, United StatesHello, · 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 · Role: Regulatory ...
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Regulatory Affairs Associate
1 week ago
INTELLECTT INC Alameda, United StatesRole: Regulatory Affairs Associate · Location: Alameda, CA · Duration: 12 Months · Job Description · Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval. · Au ...
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Regulatory Affairs Associate
4 days ago
Collabera Alameda, United StatesJob Description · Job Description · Emerging Regulations team- manages regulations and works with cross function teams. · Regulations can be very narrow and specific. · Analytical, proactive, communication skills, must do research and prep work to understand regulations before me ...
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Regulatory Affairs Associate
1 week ago
Exelixis Alameda, United StatesSUMMARY/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 ...
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Associate Director, Regulatory Affairs
5 days ago
Cytokinetics South San Francisco, United StatesReporting to the Senior Director, Regulatory Affairs, the Associate Director of Regulatory Affairs leads regulatory support for assigned programs to ensure sound regulatory planning and tactical implementation of US and international development strategies. · **Responsibilities** ...
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Gilead Sciences Foster City, United StatesFor Current Gilead Employees and Contractors: · Please log onto your · Internal Career Site · At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to dev ...
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Regulatory Affairs Associate
2 days ago
Fladger Assoc. Inc. San Mateo, United StatesJob Description · Job DescriptionFoster City, CAContract Duration: 12-18 monthsRate: NegotiableResponsibilities: · Excellent employment opportunity for a Regulatory Affairs Associate II in the Foster City, CA area. (Onsite Role) · Contractor must meet the company site requirement ...
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Regulatory Affairs Associate
6 days ago
Apex Systems Mountain View, United StatesClient: IRIDEX · Position: Regulatory Affairs Associate · Location: Mountain View, CA · Estimated Duration: The client approximates that this project may last up to 5 months. However, there is no guarantee of employment for any length of time. · Pay Rate Range: $35 - $45/hr ...
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Regulatory Affairs Associate
1 week ago
Apex Systems Mountain View, United StatesEstimated Duration: · The client approximates that this project may last up to 5 months. However, there is no guarantee of employment for any length of time. · Pay Rate Range: $35 - $45/hr · IRIDEX Corporation is a medical device manufacturer and operates in a global regulated e ...
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Summer Associate, Corporate Affairs
1 week ago
Vir Biotechnology, Inc. San Francisco, United StatesVir Biotechnology, Inc. is an immunology company focused on combining cutting-edge technologies to treat and prevent infectious diseases and other serious conditions. Vir has assembled two technology platforms that are designed to stimulate and enhance the immune system by exploi ...
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DermBiont Emeryville, CA, United StatesOrganization: · DermBiont is a clinical stage biotech company with multiple active INDs enabling multiple Phase 2 clinical trials. Assuming positive results in the current trials the two lead products will advance to Phase 3 trials in the coming year or two. The two lead product ...
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Regulatory Affairs CMC Associate
4 days ago
Fladger Assoc. Inc. San Mateo, United StatesJob Description · Job Description · Foster City, CA · Contract Duration: 6-18 months · Rate: Negotiable · Responsibilities: · Excellent employment opportunity for a Regulatory Affairs CMC Associate in the Foster City, CA area. Bay area candidates ONLY · Provide Regulatory C ...
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Regulatory Affairs CMC Associate
1 week ago
The Fountain Group San Mateo, United StatesOverview: · 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 requi ...
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Regulatory Affairs CMC Associate
2 days ago
Fladger Assoc. Inc. San Mateo, United StatesJob Description · Job DescriptionFoster City, CAContract Duration: 6-18 monthsRate: NegotiableResponsibilities: · Excellent employment opportunity for a Regulatory Affairs CMC Associate in the Foster City, CA area. Bay area candidates ONLY · Provide Regulatory CMC support for bio ...
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Principal Regional Operations Specialist
1 week ago
PG&E Corporation Oakland, United StatesRequisition ID # 155789 · **Job Category**: Business Operations / Strategy · **Job Level**: Manager/Principal · **Business Unit**: Customer & Enterprise Solutions · **Work Type**: Hybrid · **Job Location**: Oakland · Department Overview · Customer and Enterprise Solutions is devo ...
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Finance Associate, Global Affairs
5 days ago
META Menlo Park, United StatesFinance and Business Planning is a highly mission driven organization - our mission is to enable Meta to plan, prioritize, and execute as effectively as possible. We take a uniquely long-term view towards business problems. It is critical that we operate with an independent and o ...
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Finance Associate, Global Affairs
1 week ago
Meta Menlo Park, United StatesFinance and Business Planning is a highly mission driven organization - our mission is to enable Meta to plan, prioritize, and execute as effectively as possible. We take a uniquely long-term view towards business problems. It is critical that we operate with an independent and o ...
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Associate Dean, Student Affairs
5 days ago
Foothill De Anza Los Altos Hills, United States· Associate Dean, Student Affairs · HR EMPLOYMENT/CAREERS · Closing Date: 05/17/24** · **Any complete applications received after the closing date will only be forwarded to the hiring committee at their request. · SALARY GRADE: A2/A3 - I · FULL SALARY RANGE: $139, $153,638. ...
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Finance Associate, Global Affairs
1 week ago
META Menlo Park, United StatesFinance and Business Planning is a highly mission driven organization - our mission is to enable Meta to plan, prioritize, and execute as effectively as possible. We take a uniquely long-term view towards business problems. It is critical that we operate with an independent and o ...
Regulatory Affairs Associate - Alameda, United States - GForce Life Sciences
Description
Regulatory Affairs Associate - On-site in Alameda, CATerm & Start
1-year contract with possibility to extend, starting ASAP
On-site in Alameda, CA
Pay Rate:
Up to $40-48/hr based on experience ($80-96k)
FT hours, M-F 8a-5p
Business Unit:
Diabetes Care
Interview Process: 1 interview with hiring manager and then interview with manager's leadership
Summary
This role would work in the Emerging Regulations team of the Diabetes Care Division, managing narrow and specific regulations with cross-functional teams.
The ideal candidate will have strong analytical skills, proactive communication skills, and strong organizational and documentation skills.Day-to-Day Duties
Identify gaps in processes or product design (documentation)
File necessary applications and handle all government interactions regarding the regulation process for products requiring governmental approval
Review/approve engineering study protocols/reports and validation study protocols/reports
Review and assess emerging regulations
Qualifications
Recent experience with medical device design controls ideal
Understanding of engineering change control process
Familiarity with Agile PLM system
May require an advanced degree and 2-4 years of direct experience in the field
Relies on analytical thinking and judgment to plan and accomplish goals
A wide degree of creativity and latitude is expected
Open to Engineering, Quality, or Manufacturing backgrounds who are interested in a career in Regulatory Affairs
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