Top 5 Regulatory affairs specialist Jobs in Claremont Ca

Regulatory Affairs Specialist II
City of Hope —Duarte, CA
- $40.82 - $63.27 an hour
- Full-time
- Mid-level
- Master's degree
- Bachelor's degree
Staff International Regulatory Affairs Specialist
Stryker —Irvine, CA
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- Full-time
- Engineering
- Mid-level
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Regulatory Affairs Specialist II
Prolacta Bioscience —Duarte, CA
- $43.75 - $49.00 an hour
- Full-time
- Hybrid work
- Mid-level
- Residential
- Bachelor's degree
- Health insurance
- Paid time off
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Senior Specialist Regulatory Affairs
Stryker —Irvine, CA
- $95,800 - $159,600 a year
- Full-time
- Engineering
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2d
Sr. Regulatory Affairs Specialist - Ad/Promo
Prolacta Bioscience —Duarte, CA
- $112,000 - $125,000 a year
- Full-time
- Hybrid work
- 6 years
- Residential
- Bachelor's degree
- Health insurance
- Paid time off
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Regulatory Affairs Specialist II

City of Hope -
Duarte, CA

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Job Details

Full-time
$40.82 - $63.27 an hour

Qualifications

FDA submissions
Institutional Animal Care and Use Committees (IACUCs) guidelines compliance
Mid-level
Investigational new drug (IND) applications
Master's degree
Bachelor's degree
Scientific protocols
Laboratory standard operating procedures
Clinical data report preparation
Clinical trial standard operating procedures
Regulatory submission editing and review
Communication with regulatory authorities for clinical trials
Clinical quality assurance standards
Documentation Handling
Clinical trial support in drug product development
Clinical consent forms
Ethical review application preparation
Standard operating procedures (SOPs)
Project stakeholder communication
Editing
Cross-functional communication
Under 1 year
Research compliance quality assurance records management

Full Job Description

Join the forefront of groundbreaking research at the Beckman Research Institute of City of Hope, where we're changing lives and making a real difference in the fight against cancer, diabetes, and other life-threatening illnesses. Our dedicated and compassionate faculty and staff are driven by a common mission: Contribute to innovative approaches in predicting, preventing, and curing diseases, shaping the future of medicine through cutting-edge research.

A Regulatory Affairs Specialist II position is available in the Diamond Research Laboratory. You will assist and support internal and external PIs, for timely and accurate submissions related to clinical protocols under their jurisdiction. This may also include preparation, review, and compilation of Investigational New Drug Application (IND) Annual Reports; protocol review for protocol amendments along with review of documentation for informational amendments, and review of safety documentation. In preparation for these submissions, you will be responsible for interacting with internal personnel to include investigators and their staff (clinical research nurse and coordinator, biostatistician, and scientific leads), as well as Manufacturing, Quality Control, and Quality Assurance staff. You will also assist with regulatory maintenance, amendments/approvals (IRB, IBC, and IACUC), training documentation, etc. to ensure regulatory compliance.

As a successful candidate, you will:

Lead in the design and development of clinical protocols, consent forms, SOPs, and other documents required by the project.
Ensure compliance with protocol, regulatory and overall clinical and quality objectives.
Compose, edit or review laboratory SOPs, and review/revise manufacturing and quality testing SOPs.
Write pre-clinical and clinical documents, handle submissions for iRIS and respond to regulatory authorities.
Communicate critical information related to project timelines and core project teams.
Act independently to determine methods and procedures of new projects.

Your qualifications should include:

Bachelors degree in a scientific discipline or equivalent with a Masters degree preferred.
2-5 years of regulatory affairs experience with a Bachelors or 0-2 years of regulatory affairs experience with a Masters
Preferred experience within regulatory affairs, clinical trials management or relevant scientific field
RAPS, SOCRA or ACRP Certification is preferred but not required

City of Hope employees pay is based on the following criteria: work experience, qualifications, and work location.

City of Hope is an equal opportunity employer.

To learn more about our Comprehensive Benefits, please CLICK HERE.

Apply Now

Refine Your Search

regulatory affairs specialist jobs in claremont ca

Regulatory Affairs Specialist II

Staff International Regulatory Affairs Specialist

Regulatory Affairs Specialist II

Senior Specialist Regulatory Affairs

Sr. Regulatory Affairs Specialist - Ad/Promo

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