Associate Director, Regulatory Affairs

📋 Description

• Develop and implement robust US regulatory strategies for assigned development and commercial
• Provide strategic, operational, and tactical regulatory guidance across pre-approval and
• Serve as a primary point of contact with the FDA and lead or participate in regulatory meetings as
• Prepare internal teams for interactions with regulatory authorities and ensure effective
• Lead and oversee the preparation of regulatory dossier content for INDs, BLAs, and NDAs.
• Critically review submission documents to ensure quality, consistency, and compliance with

🎯 Requirements

• Minimum 8 years of regulatory affairs experience within biopharmaceutical organizations, including
• PhD or PharmD preferred.
• Experience working in rapidly growing pharmaceutical or biopharmaceutical organizations is
• Thorough understanding of the drug development lifecycle, with expertise in orphan drugs and
• Demonstrated experience coordinating critical regulatory documentation supporting the approval of
• Proven experience interacting directly with regulatory authorities.

🎁 Benefits

• Annual base salary hiring range of $164,000–$225,500 USD, with individual compensation determined
• Eligibility to participate in short-term and long-term incentive programs, subject to applicable
• Comprehensive benefits package, including retirement savings plans and health benefits.
• Opportunity to work in a global, science-driven environment focused on advancing innovative
• Strategic exposure across the full product lifecycle, from development and regulatory submissions
• Close collaboration with scientific, clinical, medical, legal, quality, pharmacovigilance, and