Associate Director – Regulatory Affairs

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

📋 Description

• Act as the global regulatory lead for designated development initiatives.

• Establish regulatory strategies and development pathways that are suitable for each stage.

• Create regulatory strategies specifically for rare diseases and programs with accelerated development timelines.

• Prepare applications for orphan designation and facilitate expedited development pathways.

• Collaborate with Clinical Development, Translational Sciences, Nonclinical, CMC, other functional teams, and CROs.

• Incorporate regulatory considerations into development planning and significant program decisions.

• Offer regulatory insights on study designs, translational biomarkers, dose selection, and safety considerations for first-in-human studies.

• Provide guidance to ensure efficient decision-making while balancing the pace of development, scientific rigor, and program options.

• Lead preparations for and engagements with global health authorities.

• Develop briefing materials, meeting strategies, and written communications.

• Oversee and contribute to regulatory submissions, which include INDs, CTAs, amendments, annual reports, and other filings.

• Keep abreast of changing regulatory guidance and industry trends.

• Assess regional regulatory requirements and opportunities to bolster global development efforts.

⛳️ Requirements

• Preferred: Advanced degree in a scientific discipline (Ph.D., Pharm.D., M.D., or equivalent).

• For Associate Director: 7+ years of experience in the pharmaceutical/biotechnology industry, including at least 6 years in regulatory roles.

• For Director: 10+ years of experience in the pharmaceutical/biotechnology sector, with no less than 8 years in regulatory positions.

• Proven track record of regulatory success, having led and supported IND-stage programs through critical regulatory milestones.

• Experience with rare diseases and knowledge of accelerated or expedited regulatory pathways.

• Demonstrated success in leading and supporting communications with regulatory authorities, including briefing documents, meetings, and written responses.

• Strong understanding of early clinical development, translational biomarkers, and safety considerations for first-in-human studies.

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

• Familiarity with various therapeutic modalities, including oligonucleotides and small molecules.

• Ability to articulate regulatory risks, opportunities, and development trade-offs.

• Willingness and capability to operate in situations with limited precedent and incomplete data while maintaining regulatory credibility.

🏝️ Benefits

• Patient Days.

• A culture influenced by company values.

• Decentralized operating model that allows decision-making authority close to the scientific work.

• Opportunities for career ownership and development.

• A collaborative, fast-paced, and data-driven work environment.

• Access to learning and development resources.

• Comprehensive and market-competitive health, welfare, and retirement programs.

• Flexible PTO.

• Rapid career advancement opportunities for high performers.

• Potential to engage in multiple GondolaBio programs across various therapeutic areas.