Regulatory Affairs Internship

Job Title: Regulatory Affairs Internship

Location: South San Francisco, CA/hybrid (local candidates only)

Reports to: Director or above (Regulatory Affairs)

Full/Part-Time: Summer Intern

Regular/Temporary: Temporary

 

Job Summary:

The 12-week summer internship provides students with an overview of Regulatory Affairs (RA) and knowledge of health authority requirements.  The successful applicant will have hands-on experience developing the skills to prepare regulatory submission documents for products in development. The successful applicant facilitates the submission of documents to regulatory agencies.  Finally, the student will have the opportunity to conduct due diligence on a specific regulatory topic for their summer internship project.    

What You Will Accomplish:

• Develop a framework of understanding and context of use of Food and Drug Administration (FDA), ICH guidelines, and other Health Authority regulations for drug development (as applicable). 

• Support and prepare regulatory documents such as investigational new drug applications and clinical trial applications. 

• Identify and collaborate with key stakeholders such as Clinical Development, Project Management, Nonclinical, Toxicology, and quality assurance, etc.    

• Ensures effective coordination of the review & approval of submission/project documents, as required to ensure regulatory compliance.  

• Contribute to regulatory strategies for drug development, clinical study planning, and project implementation by participating in project teams. 

• Perform due diligence activities to inform regulatory strategies for drug development. 

Qualifications:

• A successful candidate may be pursuing an advanced degree (MS, PharmD, or Ph.D.). Must have an undergraduate degree in science, technology, or engineering.  

• Fundamental understanding of drug development shown by theoretical experience. Knowledge of current Food and Drug Administration (FDA) regulations, and guidelines, is desired. 

• Proven leadership capabilities in an organizational setting (campus/community or employment activities) are desired. 

• Able to work independently and be part of a group with curiosity and flexibility. 

 

Compensation: The hourly rate for this position is $30.00/hr (pursuing MS), $35.00 (pursuing PharmD/PhD), and $27.00/hr (pursuing BS) USD.

Equal Opportunity for Diversity & Inclusion

SonoThera provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.