Remote Regulatory Strategy Lead for Global Trials

Parexel; United States; Remote; USD 140,000 - 190,000; Full time

Benefits offered by this job

Health insurance

Tuition reimbursement

Vacation time

HSA/FSA

Work-life balance

401(k) with company match

Pet insurance

Job summary

Parexel, a leading global clinical development partner, seeks a Regulatory Strategy Consultant to own regulatory strategy across programs in a remote capacity in the United States. You will drive major submissions, authority engagement models, and lifecycle planning with cross-functional partners to advance clinical programs.

You’ll lead strategic regulatory decisions, guide development timelines, and collaborate with biopharma partners to shape pathways that bring new therapies to patients.

Qualifications

• Bachelor’s degree in life sciences or related field with strong regulatory experience.
• 10+ years in regulatory affairs, clinical development, or related field.
• Experience with vaccine and/or biologic products is required.
• Deep knowledge of ICH-GCP, FDA and international regulatory requirements, and clinical trial processes.
• Experience with regulatory tracking systems and electronic submission tools.
• Excellent communication, strategic planning, and leadership abilities.

Responsibilities

• Own regulatory strategy across significant programs or portfolios and align with business goals.
• Provide leadership on major regulatory decisions, including submission strategies and risk mitigation.
• Lead planning and execution of high-impact regulatory submissions with cross-functional teams.
• Develop long-range development and lifecycle management plans for regulatory pathways.
• Collaborate with clinical, scientific, and commercial teams to align strategy with timelines.
• Monitor regulatory landscape changes and advise on adaptations to submissions.

Skills

Regulatory strategy

Regulatory affairs

Clinical development

Cross-functional leadership

ICH-GCP knowledge

FDA/regulatory requirements

Education

Bachelor’s degree in life sciences

Advanced degree (M.D., Ph.D., or MBA) or RAC preferred

Tools

Regulatory databases

Submission management systems

Clinical development platforms

Job description

Parexel, a leading global clinical development partner, seeks a Regulatory Strategy Consultant to own regulatory strategy across programs in a remote capacity in the United States. You will drive major submissions, authority engagement models, and lifecycle planning with cross-functional partners to advance clinical programs.

You’ll lead strategic regulatory decisions, guide development timelines, and collaborate with biopharma partners to shape pathways that bring new therapies to patients.