Executive Director - Regulatory Affairs CMC and Device Regulatory
September 17
Description
• Lead and oversee all CMC regulatory activities and execution for drug-device combination products. • Work closely with cross-functional teams to guide the development, submission, and approval processes for combination products. • Guide and ensure compliance with global regulatory requirements throughout the product lifecycle. • 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. • Identify and assess regulatory risks associated with combination products and develop mitigation strategies to address potential challenges.
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. • Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless • Ability to travel up to 10% travel
Benefits
• A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless • Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly • 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 • Commitment to growing you professionally and providing access to resources to further your development • Apogee offers regular all team, in-person meetings to build relationships and problem solve
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