· 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
· BS Degree in a Scientific discipline
· 10+ years Biopharmaceutical and/or Pharmaceutical experience
· FDA interface experience
· 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 Group, we have a set of core values that we live and breathe each day. Every benefit offered here at Azzur is designed to uphold our 4 core values; Putting Others First, Having the Courage to Take Action, Taking Personal Responsibility and Having Fun.
It is our mission to serve our communities, build positive and established relationships, create a healthy and fun work environment, ensure each employee and their families are healthy and thriving, grow each employee professionally with one of our customized training programs and keep a clear and open line of communication.
We are an equal opportunity employer and promote diverse culture, ethnicity, gender and age in our workplace. We believe that promoting diversity plays an important role in developing top quality talent, fostering greater innovation and creativity, and enhancing our relationships with customers and the communities in which we operate.
If philanthropy, long lasting relationships, a clear career path forward and a positive, transparent and fun company culture are something you are looking for in your next role, Azzur is the place for you.