Regulatory Affairs Postdoc Fellow - Global Submissions

NU USA Northeastern University; Palo Alto (CA); On-site; USD 66,000 - 94,000; Full time

Benefits offered by this job

Comprehensive benefits package

Job summary

Northeastern University, in partnership with Eidos and BridgeBio Pharma, offers a two-year Regulatory Affairs fellowship based in San Francisco. You will develop regulatory strategy, support labeling activities, and review promotional materials in collaboration with Clinical, Statistics, Medical Affairs, and Commercial teams.

The program focuses on Regulatory Affairs deliverables, with opportunities to contribute to broader clinical development and pharmacovigilance projects within the BBIO

Qualifications

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

Responsibilities

• Regulatory Strategy: develop regulatory strategy for Eidos development programs and familiarize with ICH, GCP, GMP guidelines.
• Global Labeling: support labeling strategy, CCDS, USPI, SmPC, SPL, and coordination with health authorities.
• Advertising & Promotion (MLR): review promotional materials and coordinate with cross-functional teams for submissions to FDA.

Skills

Excellent communication

Time management

Leadership abilities

Independent work

Education

Doctor of Pharmacy degree

Job description

Northeastern University, in partnership with Eidos and BridgeBio Pharma, offers a two-year Regulatory Affairs fellowship based in San Francisco. You will develop regulatory strategy, support labeling activities, and review promotional materials in collaboration with Clinical, Statistics, Medical Affairs, and Commercial teams.

The program focuses on Regulatory Affairs deliverables, with opportunities to contribute to broader clinical development and pharmacovigilance projects within the BBIO