Welcome Back

Google icon Sign in with Google
OR
I agree to abide by Pharmadaily Terms of Service and its Privacy Policy

Create Account

Google icon Sign up with Google
OR
By signing up, you agree to our Terms of Service and Privacy Policy
Instagram
youtube
Facebook

Intern - Pdm - Cmc Regulatory

0-2 years
$19 – $55 / hourly
10 Dec. 16, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Intern – PDM CMC Regulatory | Foster City, California, United States
Department: Regulatory Affairs – CMC (Chemistry, Manufacturing, and Controls)
Employment Type: Internship | Full-Time
Location: Onsite

Company Overview:
Gilead Sciences is a leading biopharmaceutical company dedicated to advancing global health. For over 35 years, Gilead has innovated in HIV, viral hepatitis, COVID-19, cancer, and other therapeutic areas, delivering therapies that transform lives worldwide.

Position Overview:
The PDM CMC Regulatory Intern will gain hands-on experience contributing to regulatory submissions for investigational and marketed products. This internship provides exposure to CMC regulatory operations, cross-functional collaboration, and professional development in a real-world pharmaceutical environment.

Key Responsibilities:

  • Support the CMC Regulatory Affairs team in the preparation of regulatory submission documents, including notifications, supplements, and annual reports for clinical trial applications and marketing authorizations.

  • Assist in compliance with regulatory requirements, company policies, and procedures for assigned territories.

  • Develop regulatory knowledge and skills under guidance and supervision of the Foster City CMC RA team.

  • Contribute to local process improvements impacting the CMC RA department, including regulatory and change control systems.

  • Collaborate across cross-functional teams within a matrixed organization.

  • Present a final project or presentation (PPT) at the conclusion of the internship.

Required Qualifications:

  • Minimum age: 18 years.

  • GPA of 2.8 or higher.

  • Authorized to work in the U.S. without sponsorship, or eligible via CPT/OPT through your university.

  • Full-time enrollment in a Bachelor’s, Master’s, MBA, PhD, or PharmD program at an accredited U.S. institution.

  • Rising Sophomore, Junior, or Senior undergraduates, or Graduate/Doctoral students.

  • Available for a 10–12 week consecutive internship between May and August.

  • Willing to relocate and work onsite at the Foster City location.

Preferred Qualifications:

  • Degree focus in Chemistry, Biology, Regulatory Affairs, or closely related disciplines.

  • Proficiency with MS Office Suite.

  • Strong problem-solving, organizational, and analytical skills.

  • Ability to work independently and collaboratively in a fast-paced environment.

  • Commitment to diversity, equity, and inclusion.

Gilead Core Values:

  • Integrity: Doing what’s right.

  • Inclusion: Encouraging diversity.

  • Teamwork: Working together.

  • Excellence: Being your best.

  • Accountability: Taking personal responsibility.

Compensation & Benefits:

  • Hourly Range: $19 – $55 (depending on education and location).

  • Paid holidays, sick time, and housing stipends for eligible interns.

Equal Opportunity Employer:
Gilead Sciences fosters a diverse and inclusive workplace. Applicants requiring accommodation may contact ApplicantAccommodations@gilead.com.

Job Requisition ID: R0048454