Regulatory Affair Director - Global Regulatory Leader (Rare Disease)
Based in the United StatesFull-TimeDirector
Salary not disclosed
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Job Details
- Experience
- 4–10+ years of relevant regulatory or pharmaceutical development experience
- Required Skills
- Leadership
Requirements
- Advanced degree (Doctorate, Master’s, or Bachelor’s).
- 4–10+ years of relevant regulatory or pharmaceutical development experience.
- 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.
- Ability to drive alignment across global stakeholders.
- Experience working in rare disease, biotech, or complex therapeutic areas is highly desirable.
- Excellent communication skills.
Responsibilities
- 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.
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