Regulatory Affairs Fellow — Biopharma Submissions & Strategy

Northeastern University; San Francisco (CA); On-site; USD 66,000 - 94,000; Full time

Job summary

Northeastern University, in partnership with Eidos (BridgeBio), offers a two-year Regulatory Affairs fellowship based in San Francisco. The program focuses on regulatory strategy, labeling, and interactions with health authorities, with opportunities across clinical development, pharmacovigilance, and related areas.

The fellow will work with cross-functional teams and gain experience in preparing regulatory submissions and labeling documentation while pursuing continued professional development

Qualifications

• Doctor of Pharmacy degree from ACPE-accredited institution.
• Eligible for pharmacist licensure in Massachusetts.
• Excellent oral and written communication skills.
• Strong time management and leadership abilities.
• Ability to work independently and take initiative on projects at both the industry site and Northeastern.

Responsibilities

• Develop and implement regulatory strategy to support Eidos development programs.
• Build proficiency in the Veeva regulatory management system for submissions (CTA/IND/NDA/MAA).
• Maintain knowledge of ICH, GCP, GMP and global guidelines for compliance.
• Collaborate with Clinical, Statistics, Medical Affairs, Commercial, and Nonclinical teams.
• Support regulatory interactions with health authorities, including meeting requests and briefing documents.
• Prepare responses to labeling-related queries and manage labeling strategy.

Skills

Pharmacist licensure

Communication skills

Time management

Leadership

Independent work

Education

Doctor of Pharmacy degree

Job description

Northeastern University, in partnership with Eidos (BridgeBio), offers a two-year Regulatory Affairs fellowship based in San Francisco. The program focuses on regulatory strategy, labeling, and interactions with health authorities, with opportunities across clinical development, pharmacovigilance, and related areas.

The fellow will work with cross-functional teams and gain experience in preparing regulatory submissions and labeling documentation while pursuing continued professional development