Remote Executive Director

Summary

Join Apogee Therapeutics as an Executive Director, Regulatory Affairs CMC and Device Regulatory to lead and oversee all CMC regulatory activities and execution for drug-device combination products. This role requires a deep understanding of CMC regulatory requirements and the ability to navigate complex regulatory landscapes for biologics.

Requirements

• Advanced degree in Chemistry, Pharmaceutical Sciences, Biochemistry, or a related field. Ph.D. preferred
• Minimum of 12-15 years of experience in Regulatory Affairs CMC within the pharmaceutical/biotechnology industry with significant experience in drug-device combination products
• Proven track record of successful CMC regulatory submissions and experience across multiple regions (e.g., US, EU, and Canada)
• In-depth understanding of the development processes for drug device combination products, including manufacturing, quality control, and clinical evaluation
• In-depth knowledge of global regulatory requirements
• Excellent/Strong communication skills with an ability to present to a variety of stakeholders and tailor message accordingly
• Strategic thinker with strong problem-solving abilities and attention to detail
• Ability to work effectively in a fast-paced, dynamic environment, managing multiple priorities and projects

Responsibilities

• Develop and implement comprehensive global CMC regulatory strategies for investigational drug-device combination products, ensuring alignment with product development and business goals
• Stay abreast of evolving global regulatory landscapes for combination products and proactively adapt strategies to maintain compliance and competitive advantage
• Lead the preparation and review of CMC regulatory submissions, including INDs, NDAs, BLAs, MAAs, CTAs, and amendments
• Oversee the preparation of high-quality CMC sections of regulatory submissions and ensure timely submissions
• Collaborate with R&D, Manufacturing, Quality, and Clinical teams to gather necessary data and ensure regulatory requirements are integrated into product development and manufacturing processes
• Provide strategic advice and guidance to senior management on CMC regulatory matters based on health authority feedback and global regulatory trends
• Identify and assess regulatory risks associated with combination products and develop mitigation strategies to address potential challenges
• Maintain a deep understanding of current and emerging global regulatory requirements for combination products and ensure the organization is prepared to meet these demands

Benefits

• Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
• Flexible PTO
• Two, one-week company-wide shutdowns each year