Associate Director – Regulatory Affairs

This is a fully remote position, open to applicants in United States.

📋 Description

• Act as the global regulatory leader for designated development programs, establishing regulatory strategies and development pathways appropriate for each stage.

• Formulate regulatory strategies for programs related to rare diseases and accelerated development, which includes handling orphan designation applications and fast-tracked development pathways.

• Collaborate closely with Clinical Development, Translational Sciences, Nonclinical, CMC, and other functional teams, including engaging with CROs as necessary, to incorporate regulatory considerations into development planning and major program decisions.

• Offer strategic regulatory insights on study design, translational biomarkers, dose selection, and first-in-human safety concerns.

• Provide regulatory direction to facilitate efficient and informed decision-making, balancing development speed with scientific integrity and long-term program flexibility.

• Lead preparations for and engage with global health authorities, including developing briefing documents, strategizing meetings, and managing written correspondence.

• Directly contribute to the planning, preparation, and submission of high-quality regulatory documents (e.g., IND, CTA), amendments, annual reports, and other regulatory filings.

• Stay informed about evolving regulatory guidelines and industry trends that may influence development strategies.

• Aid global development initiatives by assessing regional regulatory requirements and opportunities.

⛳️ Requirements

• An advanced degree in a scientific field (Ph.D., Pharm.D., M.D., or equivalent) is preferred.

• For the Associate Director role, a minimum of 7 years of experience in the pharmaceutical/biotechnology industry is required, with at least 6 years in a regulatory capacity; for the Director role, at least 10 years of industry experience is needed, with a minimum of 8 years in regulatory roles.

• A proven history of regulatory achievements, including leading and supporting IND-stage programs through significant regulatory milestones and facilitating development progress.

• Experience with rare diseases and a strong understanding of accelerated or expedited regulatory pathways.

• Established track record in leading and supporting engagements with regulatory authorities, including developing briefing documents, conducting meetings, and composing written responses.

• In-depth knowledge of early clinical development, translational biomarkers, and considerations for first-in-human safety.

• Excellent cross-functional leadership and communication skills, both written and verbal.

🏝️ Benefits

• Patient Days, where we have the privilege of hearing directly from individuals living with the conditions we aim to impact and learning how we can enhance our efforts throughout the year.

• A culture driven by our core values: prioritizing patients, thinking independently, embracing radical transparency, valuing every minute, and letting science guide us.

• A steadfast commitment to always placing patients first.

• A decentralized model that empowers our program teams to concentrate on advancing science and assisting patients, designed to minimize bureaucracy and place decision-making authority in the hands of those closest to the scientific work.

• An environment where you take ownership of your vision—both for your program and your career trajectory.

• A collaborative, fast-paced, and data-centric environment that inspires us to continuously perform at our best.

• Access to learning and development resources to help you achieve peak professional excellence.

• A comprehensive and competitive compensation and benefits package (Base salary, Performance Bonus, Equity, health, welfare, and retirement programs).

• Flexible Paid Time Off (PTO).

• Opportunities for rapid career advancement for high performers.

• Potential to engage with multiple GondolaBio Pharma programs across various therapeutic areas over time.

• A strong commitment to Diversity, Equity, and Inclusion.