Remote Regulatory Strategy Leader

Parexel; Denver (CO); Remote; USD 140,000 - 200,000; Full time

Benefits offered by this job

Health insurance

Tuition Reimbursement

Vacation/Holiday/Sick Time

Flexible Spending & Health Savings

Work/Life Balance

401(k) with Company match

Pet Insurance

Job summary

Parexel is seeking a Regulatory Strategy Consultant to own regulatory strategy across significant programs, shape pathways, and guide lifecycle planning in a remote capacity.

You will lead high‑impact submissions, engage with authorities, and collaborate with clinical, scientific, and commercial teams to drive strategies that accelerate development while ensuring regulatory compliance across global markets.

Qualifications

• Bachelor’s degree in life sciences or related field; advanced degree preferred.
• 10+ years in regulatory affairs or clinical development.
• Experience with vaccine/biologic products is required.
• Strong knowledge of ICH-GCP and FDA/regional requirements.
• Experience with regulatory tracking systems and submission tools.

Responsibilities

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

Skills

Regulatory strategy

Strategic planning

Cross-functional leadership

Communication

Regulatory leadership

Education

Bachelor’s degree in life sciences

Advanced degree preferred

Tools

Regulatory databases

Submission tools

Clinical platforms

Job description

Parexel is seeking a Regulatory Strategy Consultant to own regulatory strategy across significant programs, shape pathways, and guide lifecycle planning in a remote capacity.

You will lead high‑impact submissions, engage with authorities, and collaborate with clinical, scientific, and commercial teams to drive strategies that accelerate development while ensuring regulatory compliance across global markets.