Regulatory Specialist
HeartFlowSalary not specified
- Full Time
- Junior (1 to 2 years)
Not SpecifiedCompensation
Junior (1 to 2 years)Experience Level
Full TimeJob Type
UnknownVisa
BiotechnologyIndustries
Requirements
Candidates require a Bachelor’s degree in a life science or adjacent field, with a minimum of 3 years of experience in regulatory affairs supporting clinical trials, and preferred experience in oncology and/or cell therapy. Knowledge of ICH/GCP guidelines and other relevant regulations is essential, along with strong verbal and written communication skills and proficiency in organizational, time management, and interpersonal skills.
Responsibilities
The Sr. Regulatory Affairs Specialist will prepare and process all regulatory documentation for FDA, EMA, and other regulatory bodies, including new submissions, annual reports, amendments, adverse events, and reportable events. They will actively participate in regulatory and cross-functional team meetings, providing advice and support on regulatory aspects of clinical trials, draft study documents such as protocols, informed consent forms, and case report forms, and ensure all study information on ClinicalTrials.gov is current and accurate. Furthermore, they will maintain awareness of evolving FDA and EMA regulations, communicating significant changes to relevant stakeholders.
Skills
Regulatory Documentation
FDA
EMA
Clinical Trials
Regulatory Submissions
ICH/GCP Guidelines
Regulatory Strategies
Protocol Drafting
Informed Consent Forms
ClinicalTrials.gov Management
Regulatory Compliance
Communication Skills
Organizational Skills
Time Management
Interpersonal Skills
Orca Bio
Develops and commercializes cell therapies
About Orca Bio
Orca Bio operates in the biotechnology sector, specifically focusing on cell therapies that utilize the body's own cells to treat diseases. The company works to enhance these therapies, aiming to make them safer and more effective for patients. Orca Bio's products are primarily used by healthcare providers who administer these therapies to patients as part of their treatment plans. Unlike many competitors, Orca Bio emphasizes a strong team culture and values communication with stakeholders, keeping them informed about the company's progress and developments. The goal of Orca Bio is to improve patient outcomes through advanced cell therapies, addressing conditions that currently have limited treatment options.
Key Metrics
Menlo Park, CaliforniaHeadquarters
2016Year Founded
$186.8MTotal Funding
SERIES_DCompany Stage
Biotechnology, HealthcareIndustries
51-200Employees