Senior Regulatory Strategy Lead — Remote

Parexel

Providence (RI)

Remote

USD 140,000 - 200,000

Full time

14 days+

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Benefits offered by this job

Health, Vision & Dental Insurance

Tuition Reimbursement

Vacation/Holiday/Sick Time

Flexible Spending & Health Savings

Work/Life Balance

401(k) with Company match

Pet Insurance

Job summary

Parexel, a global clinical development leader, seeks a Regulatory Strategy Consultant to join our team remotely. You will own regulatory strategy across significant programs, lead authority engagements, and drive high-impact submissions while collaborating with clinical, scientific, and commercial teams to align development with regulatory timelines.

You’ll work across therapeutic areas to shape long-range development and lifecycle plans, monitor regulatory landscape changes, and provide

Qualifications

Bachelor's degree in life sciences, pharmacy, medicine, or related field, or equivalent professional experience.
10+ years of experience in regulatory affairs, clinical development, or related field.
Previous 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, electronic submission tools, and clinical development platforms
Excellent communication, strategic planning, and problem-solving skills with demonstrated leadership ability

Responsibilities

Own regulatory strategy across significant programs or portfolios, ensuring alignment with business objectives and regulatory requirements
Provide leadership on major regulatory decisions, including authority engagement models, submission strategies, and risk mitigation approaches
Lead the planning and execution of high-impact regulatory submissions, coordinating cross-functional teams and ensuring compliance with regulatory requirements
Develop and implement long-range development and lifecycle management plans that optimize regulatory pathways and commercial outcomes
Collaborate with clinical, scientific, and commercial teams to align regulatory strategy with development timelines and market opportunities
Monitor regulatory landscape changes and provide strategic recommendations to adapt development and submission approaches