Our client is a rapidly growing clinical-stage biotechnology company specializing in innovative antibodies and antibody-drug conjugates to target tumors and harness the immune system for cancer treatment. They have retained us to assist in their search for a Head of Regulatory Affairs.

Major tasks and responsibilities include:

• Develop and implement regulatory and quality strategies aligned with corporate goals, and in accordance with global regulatory requirements. Lead strategic regulatory initiatives by developing and presenting comprehensive plans to board members and executive leadership, ensuring alignment with corporate objectives and regulatory compliance standards.
• Provide strategic guidance on navigating complex regulatory challenges, leveraging regulatory expertise to inform decision-making and shape corporate strategy for business success.
• Lead the preparation, submission, and management of regulatory applications (INDs, NDAs, BLAs, MAAs, etc.) to health authorities such as the FDA, EMA, and other regulatory agencies worldwide.
• Monitor and interpret evolving regulatory guidelines and requirements to ensure compliance throughout the product lifecycle.
• Collaborate closely with cross-functional teams, including Clinical Development, Medical Affairs, Quality Assurance, and Commercial, to integrate regulatory considerations into product development plans and commercial strategies.
• Serve as the primary liaison with regulatory agencies in regulatory meetings, communications, and negotiations.
• Identify potential regulatory risks and develop mitigation strategies to ensure successful regulatory outcomes.
• Stay abreast of emerging trends, regulatory developments, and competitor activities to inform regulatory strategy and decision-making.
• Build and lead a high-performing Regulatory Affairs team, providing mentorship, guidance, and professional development opportunities to team members.

 
We seek candidates with the following qualifications:

• Advanced degree in life sciences or related field (PhD, MD, or PharmD) is preferred. A Master’s degree can be considered with relevant experience.
• Must have significant experience in regulatory affairs within the pharmaceutical or biotechnology industry, with substantial time in a leadership capacity.
• Proven track record of successful regulatory submissions and approvals, with a focus on leadership in regulatory strategy.
• Pivotal experience integrating regulatory affairs and quality into corporate strategy, ensuring alignment with overarching business objectives.
• Established record of effectively communicating complex regulatory strategies and initiatives to board members and executive leadership, demonstrating strong presentation skills and an ability to influence decision-making at the highest levels of the organization.
• Demonstrated leadership in shaping the regulatory landscape within R&D, collaborating closely with cross-functional teams to integrate regulatory considerations into product development processes and accelerate time-to-market.
• Must have extensive experience in developing and implementing corporate regulatory strategies that align with business objectives, ensuring compliance with global regulations while driving sustainable growth and market competitiveness.
• Evidenced ability to thrive in a fast-paced, dynamic environment and effectively manage competing priorities.
• Requires experience leading high-performing teams, including recruiting, developing, motivating, and empowering team members. Experience working cross-functionally and delegating effectively.
• Providing clear direction and vision to team members to foster a collaborative and high-performance work environment.
• Drives innovation and continuous improvement within the team and organization. Maintains a proactive approach to personal and professional development of team members.
• Exceptional communication and influencing skills, with the ability to inspire confidence and work successfully with varied audiences, including industry partners, financial institutions, Board of Directors, fellow management, and employees.
• Must have a strong executive presence with excellent problem-solving abilities and a proactive approach to regulatory challenges.
• Entrepreneurial, collaborative, energetic self-starter with strong interpersonal and analytical skills and proven ability to work effectively with senior management as a strategic partner.
• Strong scientific orientation and the ability to establish and maintain credibility with internal and external scientific and business experts.
• Commitment to fostering a company culture that prioritizes quality and regulatory compliance, champions these principles as core values essential to organizational success, and drives initiatives to embed them throughout all levels of the company.

If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.

Fairway Consulting Group is included in Hunt Scanlon’s list of Top 40 Life Sciences Search Firms and Forbes' list of Top 150 Best Executive Recruiting Firms.