Director/Senior Director, Global Regulatory Affairs

This is a fully remote position, open to applicants in United States.

📋 Description

• Collaborate in the development and implementation of global regulatory strategies for clinical development and commercial initiatives, including the preparation and management of submissions.

• Serve as the primary contact for regulatory agencies, managing communications, meetings, inspections, and responses to inquiries.

• Supervise the preparation and submission of regulatory documents.

• Work alongside external regulatory subject matter experts (consultants) to provide strategic regulatory guidance to cross-functional teams, including Clinical, CMC, Medical Affairs, and Commercial, ensuring regulatory support aligns with business objectives.

• Offer strategic insights to leadership regarding regulatory risks and mitigation strategies.

• Keep abreast of evolving global regulatory requirements and trends, and communicate relevant regulatory requirements, guidelines, and policy changes to internal stakeholders.

• Collaborate with Quality Assurance to ensure that regulatory requirements, quality systems, and inspection readiness are aligned.

• Represent regulatory interests in product development governance committees and decision-making processes.

⛳️ Requirements

• Preferred advanced degree in life sciences, pharmacy, or a related field.

• Over 10 years of progressive experience in regulatory affairs within the biotechnology or pharmaceutical sector.

• At least 5 years of experience in the hematology or oncology domain.

• Proven track record of successful regulatory submissions and interactions with agencies.

• In-depth understanding of regulations from FDA, EMA, and other major health authorities.

• Experience with successful product approvals.

• Strong leadership skills with a minimum of 3 years managing regulatory teams.

• Excellent communication and interpersonal skills for effective collaboration across functions.

• Strategic thinker with the ability to convert complex regulatory frameworks into actionable guidance.

• Demonstrated capability to work collaboratively with both internal and external stakeholders to reach consensus in complex and ambiguous situations.

• Extensive knowledge of GxP requirements and their implementation.

• Capability to thrive in a fast-paced environment.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health, dental, and vision insurance plans.

• Retirement savings plan with employer matching.

• Opportunities for professional development and continuing education.

• Flexible work arrangements and a supportive work environment.