Remote Senior Regulatory Strategist (FDA/Biologics)

Parexel; Oregon; Hybrid; USD 110,000 - 165,000; Full time

Benefits offered by this job

Health Insurance

401(k) with Company match

Tuition Reimbursement

Vacation/Holiday/Sick Time

Flexible Spending & Health Savings

Work/Life Balance

Pet Insurance

Job summary

Parexel is seeking an experienced U.S. Regulatory Strategist to join our team in a remote capacity, supporting vaccine and biologic programs across development, registration, and post-approval lifecycle activities.

You will work with global regulatory and cross-functional teams to influence regulatory decisions and ensure timely FDA submissions. Candidates should have strong FDA experience, regulatory writing skills, and a global mindset.

Qualifications

• Practical U.S. regulatory strategy experience with direct FDA exposure.
• Experience in global regulatory organization and submissions.
• Strong regulatory writing, organization, and problem-solving skills.
• Ability to collaborate across teams and communicate clearly.

Responsibilities

• Develop U.S. regulatory strategy aligned with global development plans.
• Support or lead FDA interactions and prepare responses to agency questions.
• Plan and coordinate regulatory submissions (INDs, NDAs, BLAs, sNDA/sBLA).
• Represent U.S. regulatory requirements within global teams and decision-making.
• Support labeling updates, regulatory compliance, and post-approval activities.
• Monitor evolving FDA regulations and apply impacts to programs.

Skills

Regulatory strategy

FDA experience

Regulatory writing

Cross-functional collab

Education

Life sciences degree

Job description

Parexel is seeking an experienced U.S. Regulatory Strategist to join our team in a remote capacity, supporting vaccine and biologic programs across development, registration, and post-approval lifecycle activities.

You will work with global regulatory and cross-functional teams to influence regulatory decisions and ensure timely FDA submissions. Candidates should have strong FDA experience, regulatory writing skills, and a global mindset.