Department: Azzur Denver, LLC
Prepare proposals, conduct meetings, and address regulatory submissions and strategy needs
Interacts directly with the FDA and other regulatory bodies, as applicable
Provide interpretive guidance on regulatory requirements on projects
Provide Regulatory expertise internally and externally
Partner with clients to provide information as necessary to support their regulatory filings
Manage contractors/service providers who support Regulatory submissions goals
Remains current with regulatory intelligence and ensures submissions are aligned with current standards/expectations.
Demonstrate expert knowledge of submission or technology-related global health authority guidelines/regulations
Responsible for the overall regulatory affairs, intelligence, submissions and strategy scope including client relations and client development
Develop options for Regulatory Strategy and intelligence
Advanced Degree in a Scientific discipline
10+ years Biopharmaceutical, and/or Pharmaceutical, or Medical Device experience
Former FDA or equivalent
FDA interface experience
Regulatory dossier submissions
Advanced Therapy and/or Cell Therapy or Gene Therapy experience
Regulatory Submissions Regulatory Strategy and Regulatory Pathway strengths
Excellent communication skills
Success with training development and delivery
Our employees are fueled by an entrepreneurial spirit and the desire to make a difference in the lives of our customers, coworkers and our partners. If you’re ready to put in the work, take personal responsibility and test the limits of what’s possible, we’re ready to provide the reward.
Do What You Love
At Azzur, we look for talented individuals who take pride in the work they do. We foster employee growth by encouraging our employees to focus on doing what they love and what they do best.
Azzur is a GxP compliance and consulting organization dedicated to providing high quality, expertly backed, assistance that drives life science companies to success. We are seeking highly motivated and talented individuals to join our incredible team of skilled problem solvers. Qualified candidates must have a desire to learn, apply, engage, and adapt in the ever-changing healthcare field while simultaneously and organically exuding Azzur’s core values:
Put Others First, Courage to Take Action, Take Personal Responsibility and Have Fun!