Regulatory Affair Director - Global Regulatory Leader (Rare Disease) (36)

Regulatory Affairs Director – Global Regulatory Leader (Rare Disease)

This senior regulatory leadership role sits at the center of global drug development strategy for innovative therapies in rare disease.You will lead cross-functional global regulatory teams responsible for shaping and executing end-to-end regulatory strategy across multiple regions.The role combines strategic vision with hands-on regulatory leadership, ensuring alignment between clinical development, commercial goals, and evolving global regulatory requirements.You will influence product development pathways, labeling strategy, and regulatory approval outcomes across complex international markets.

Acting as a key partner to clinical, safety, and evidence-generation teams, you will help define how novel therapies progress from development through approval and lifecycle management.This is a high-impact leadership position where your decisions directly shape global access to life-changing medicines.The environment is fast-paced, highly collaborative, and deeply science-driven, with strong external engagement with health authorities and regulatory bodies.

Accountabilities:

• Develop and execute global regulatory strategy plans, integrating regional requirements into a unified global approach aligned with product and commercial objectives.
• Lead global regulatory teams (GRTs), ensuring alignment across clinical, safety, CMC, and evidence-generation stakeholders throughout development and lifecycle stages.
• Drive regulatory strategy for submissions including clinical trial applications, marketing authorizations, label expansions, and post-approval changes.
• Lead development and approval of target product labeling and core data sheet strategy in alignment with scientific and commercial considerations.
• Guide interactions with global health authorities, ensuring consistent messaging and effective preparation for regulatory meetings and submissions.
• Assess evolving regulatory landscapes, identifying risks, opportunities, and expedited pathways such as orphan designation, breakthrough therapy, or accelerated approval mechanisms.
• Provide strategic input into product development plans, regulatory contingencies, and cross-functional decision-making at the global level.
• Mentor and coach regulatory team members while ensuring alignment across internal and external stakeholders, including partnerships and external engagements.

Requirements:

• Advanced degree (Doctorate, Master's, or Bachelor's) with 4–10+ years of relevant regulatory or pharmaceutical development experience, depending on education level.
• Minimum 4 years of leadership or people management experience leading teams, programs, or large-scale regulatory initiatives.
• Strong expertise in global regulatory affairs, including submission strategy, agency interactions, and product lifecycle management.
• Deep understanding of regulatory frameworks, guidelines, and expedited development pathways across major global markets.
• Proven ability to interpret and communicate complex scientific and clinical data in a regulatory context.
• Strong leadership, influencing, and negotiation skills with the ability to drive alignment across global stakeholders.
• Experience working in rare disease, biotech, or complex therapeutic areas is highly desirable.
• Excellent communication skills, with the ability to engage effectively with both internal leadership and external regulatory authorities.
• Strategic thinker with the ability to anticipate regulatory risks and shape proactive mitigation strategies.

Benefits:

• Competitive base salary aligned with senior global regulatory leadership roles in the U.S.
• Annual bonus eligibility and long-term incentive opportunities, including stock-based compensation
• Comprehensive health coverage (medical, dental, and vision) for employees and eligible dependents
• Retirement savings plan with employer contributions
• Flexible work arrangements where applicable
• Generous paid time off, including award-winning vacation and holiday programs
• Paid parental leave and family support programs
• Mental health, wellness, and employee assistance resources
• Career development programs, mentoring, and continuous learning opportunities
• Additional financial, caregiving, and lifestyle support benefits