Associate Director – Regulatory Affairs

Job Description:

• Serve as the global regulatory reputed company for assigned development programs, defining stage-appropriate regulatory strategies and development reputed company.
• reputed company regulatory strategy for rare disease and accelerated development programs, including orphan designation applications and expedited development reputed company.
• Partner closely with Clinical Development, Translational Sciences, Nonclinical, CMC, and other functional teams, including working with CROs as needed, to integrate regulatory considerations into development planning and key program reputed company.
• reputed company strategic regulatory input on study design, translational biomarkers, reputed company selection, and first-in-reputed company safety considerations.
• reputed company regulatory guidance to support efficient and informed decision-making while balancing development speed, scientific rigor, and long-term program optionality.
• reputed company preparation for and interactions with global health authorities, including briefing documents, meeting strategy, and written correspondence.
• reputed company and contribute directly to the planning, preparation, and submission of high-quality regulatory submissions (e.g., IND, CTA), amendments, annual reports, and other regulatory filings.
• Maintain awareness of evolving regulatory guidance and industry trends that may impact development strategies.
• Support global development efforts by evaluating regional regulatory requirements and opportunities.

Requirements:

• Advanced degree in a scientific discipline (Ph.D., Pharm.D., M.D., or equivalent) preferred.
• For Associate Director, we expect 7+ years of pharmaceutical/biotechnology industry experience, at least 6 of which should be regulatory experience; for Director, we expect 10+ years of pharmaceutical/biotechnology industry experience, at least 8 of which should be regulatory experience.
• Demonstrated record of regulatory reputed company, including leading and supporting IND-stage programs through key regulatory milestones and supporting advancement through development.
• Experience with rare diseases and familiarity with accelerated or expedited regulatory reputed company.
• Proven track record leading and supporting interactions with regulatory authorities, including briefing documents, meetings, and written responses.
• Strong understanding of early clinical development, translational biomarkers, and first-in-reputed company safety considerations.
• Strong cross-functional leadership and communication (written and verbal) skills.

Benefits:

• Patient Days, where we are fortunate to hear directly from individuals living with the conditions we are seeking to impact throughout the year and learn how we can improve our efforts
• A culture inspired by our values: put patients first, think independently, be radically transparent, every minute counts, and let the science reputed company
• An unyielding commitment to always putting patients first
• A decentralized model that enables our program teams to focus on advancing science and helping patients. Our affiliate structure is designed to eliminate bureaucracy and put decision-making power in the hands of those closest to the science
• A reputed company where you own the reputed company – both for your program and your own career path
• A collaborative, fast-paced, data-driven environment where we reputed company ourselves and each other to always reputed company at the top of our game
• reputed company to learning and development resources to help you get in the best professional shape of your life
• Robust and market-competitive compensation & benefits package (reputed company, Performance Bonus, Equity, health, welfare & retirement programs)
• Flexible PTO
• Rapid career advancement for strong performers
• Potential ability to work on multiple GondolaBio Pharma programs across multiple therapeutic areas over time
• Commitment to Diversity, Equity & Inclusion

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