Senior Regulatory Strategy Consultant (Remote)

Parexel; Bismarck (ND); Remote; USD 150,000 - 210,000; 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 join our team in a remote capacity in the United States. You will own regulatory strategy across significant programs, guiding major regulatory decisions, authority engagement, and high-impact submissions.

You will work with biopharmaceutical partners to shape regulatory pathways, guide long-range development, and drive submissions that bring new therapies to patients, with opportunities across therapeutic areas in a fast-paced,

Qualifications

• Strong regulatory strategy and leadership experience.
• Experience in regulatory planning and lifecycle management.
• Excellent communication and strategic thinking skills.

Responsibilities

• Own and develop 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 and submission strategies
• Lead high-impact regulatory submissions, coordinating cross-functional teams and ensuring regulatory compliance
• Develop long-range development and lifecycle management plans that optimize regulatory pathways
• Collaborate with clinical, scientific, and commercial teams to align regulatory strategy with timelines and market opportunities
• Monitor regulatory landscape changes and provide strategic recommendations

Skills

Regulatory strategy

Strategic planning

Cross-functional leadership

Regulatory affairs

Clinical development

Communication

Education

Bachelor's degree in life sciences or related field

Tools

Regulatory databases

Submission management systems

Clinical development platforms

Job description

Parexel is seeking a Regulatory Strategy Consultant to join our team in a remote capacity in the United States. You will own regulatory strategy across significant programs, guiding major regulatory decisions, authority engagement, and high-impact submissions.

You will work with biopharmaceutical partners to shape regulatory pathways, guide long-range development, and drive submissions that bring new therapies to patients, with opportunities across therapeutic areas in a fast-paced,