Senior Director, Regulatory Affairs - CMC

Job Description

• Reporting to the Vice President, Regulatory Affairs, the Senior Director, Regulatory Affairs – CMC will be responsible for leading, developing, and executing CMC regulatory strategies on programs ranging from early to late-stage development, including preparation and filing of IND and NDA/MAA submission. This position will sit on cross function teams and will work closely with manufacturing, quality, and supply chain teams. This position is a hands-on role, providing both strategic and operational activities to support regulatory needs across multiple therapeutic areas.

Qualifications

• BA/BS Degree required in a health/life sciences or related field. Advanced scientific degree preferred in the sciences, or health related field or equivalent. • CMC regulatory experience in the pharmaceutical and/or biotech industry is required. • A minimum of 8 years of global CMC regulatory experience. • Strong Knowledge of current US, EU, and other global market requirements. • Experience in representing teams in front of global Health Authorities (i.e. FDA, EMA, etc.). • Experience in filing NDAs/MAAs globally. • Experience in the ability to deliver high quality CMC submission documents, including experience in writing and compiling Module 3 and corresponding Module 2 documents. • Strong strategic skills including demonstrated ability to make complex decisions. • Proven success in simultaneously handling strategic and transactional responsibilities, especially in a small-team environment. • Demonstrated excellence in project management with a proven track record of effectively managing multiple projects / priorities simultaneously. • Exceptional written and oral communication skills. • Ability to work cross-functionally and creating strong partnerships with key stakeholders. • Ability to work in a fast-paced environment with a strong attention to detail and have the agility to multi-task successfully. • Previous experience supporting Health Authority GMP inspections is preferred. • Managerial and personal development experience preferred.

Benefits

• Benefits, equity, and annual target bonus for fulltime positions