Regulatory Affairs Principal Consultant

Location: Denver, CO
Department: Azzur Denver, LLC

Job Description

What you will achieve:

 

  • Gain exposure and apply your expertise to the commissioning, qualification, and validation of key bench top and some process equipment ensuring top quality standards are being met.
  • Leverage and develop your problems solving abilities as you support the assessment of deviations, investigation, and change controls for validation activities in a regulatory setting.
  • Apply and expand your knowledge of cGxP regulations as you author and execute validation studies related to the initial startup of cGMP operations and/or change controls.
  • Provide top quality service to our valued customers and end users by ensuring all needs are met and that work performed is of the highest quality standards.
  • Grow your career through faced paced assignments with multiple clients as you continue your career with Azzur!



Job Description

Responsibilities include:

  • 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

 

Qualifications include:

  • Advanced Degree in a Scientific discipline
  • 15+ years Biopharmaceutical and/or Pharmaceutical experience
  • Former FDA or equivalent
  • 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


About Azzur

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!



Apply Now