Regulatory Pre-Award Strategy Leader

Worldwide Clinical Trials; Warszawa; Remote; PLN 320,000 - 520,000; Full time

Job summary

Worldwide Clinical Trials seeks a Regulatory Pre-award Strategy Director in Warsaw to lead pre-award activities and regulatory start-up across global projects. You will shape strategy, drive training, and coordinate with Regulatory, Therapeutic Area, and Business Development teams to win competitive bids.

You will guide cross-functional teams, manage resources, and ensure timely, compliant submissions while advancing innovative solutions in clinical trials with international scope.

Qualifications

• Demonstrated ability to define and implement regulatory strategies for pre-award activities.
• Strong collaboration across Regulatory, Clinical, and Business Development functions.
• Proven track record in bid defenses and client-facing presentations.
• Experience in global regulatory landscapes and cross-country requirements.

Responsibilities

• Direct business development and pre-award activities to create competitive proposals.
• Lead regulatory start-up and pre-award activities with emphasis on strategy and timelines.
• Drive department-wide training and coaching programs for pre-award work.
• Collaborate with regulatory, therapeutic area, and project management teams.
• Manage resources, budgets, and staffing forecasts for pre-award work.
• Represent the department in bid defenses and senior leadership meetings.

Skills

Regulatory strategy

Leadership

Bid defense

Cross-functional collaboration

Communication

Global regulatory knowledge

Education

Life science degree

Job description

Worldwide Clinical Trials seeks a Regulatory Pre-award Strategy Director in Warsaw to lead pre-award activities and regulatory start-up across global projects. You will shape strategy, drive training, and coordinate with Regulatory, Therapeutic Area, and Business Development teams to win competitive bids.

You will guide cross-functional teams, manage resources, and ensure timely, compliant submissions while advancing innovative solutions in clinical trials with international scope.