Department: Azzur Consulting LLC
Expected Salary Range: $97,000-155,000
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.
DUTIES AND RESPONSIBILITIES:
- Provide CMC Consulting services to multiple clients.
- Proactively managing CMC aspects of one or more client programs including overseeing preparation and submission of CMC submissions, including clinical trial applications.
- Develop and review CMC content to ensure it is complete, well-written, and meets all relevant requirements.
- Stay abreast of current and evolving regulatory CMC requirements, apply this knowledge to assigned projects, and provide regulatory guidance to the Quality, Manufacturing, Process Development and other functional groups and stakeholders.
- Leads projects with cross-functional teams and acts as the primary regulatory CMC contact for assigned projects.
- Participates in the design, development and implementation of regulatory strategies, regulatory risk management and contingency plans, providing recommendations in area of expertise.
- Perform regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations throughout development.
- Assist with interactions with FDA and other global regulatory authorities for assigned projects to ensure acceptance, rapid review and approval of clinical trial applications and other submissions which present CMC information.
- May perform other duties as assigned.
EDUCATION AND EXPERIENCE:
- Bachelor's Degree required (life sciences disciplines strongly preferred).
- Minimum 10 years’ experience in life sciences
- Minimum 5 years’ relevant experience in regulatory affairs or related functions in drug or biologics development.
- Experience as a regulatory contributor for global original IND, NDA, BLA MAA, filings in the US or Europe.
- Cell and Gene therapy experience preferred.
- Excellent interpersonal skills to communicate difficult concepts and persuade others.
- Strategic thinking and strong problem-solving skills with outstanding attention to detail.
- Collaborates and communicates in an open, clear, complete, timely, and consistent manner.
- Strong sense of planning and prioritization, and the ability to work with all levels of management.
- Advanced knowledge in regulatory (FDA, EMA, Health Canada, and ICH) guidelines.
- Sound knowledge of the pharmaceutical/biotechnology industry, the multiple functions and roles involved in the product development process.
- Effective decision-making skills; makes good business decisions and exercises sound judgment.
- Consistently and effectively balances decisions with imperatives for ethics and efficacy.
- Strong computer skills, including Microsoft Office Suite (Word, PowerPoint, and Excel) and Adobe Acrobat.
Azzur is a GxP compliance and consulting organization dedicated to providing high quality, expertly backed, assistance that drives life science companies to success.
No matter where you are in the product development lifecycle, Azzur is here to help you start, scale, and sustain your business. From pre-clinical manufacturing to process design and process performance qualification, Azzur Group works hand-in-hand with the world's most renowned manufactures to employ risk-based and phase appropriate GxP solutions.
With a national network of engineers and consultants, we offer comprehensive quality assurance and regulatory compliance, and validation services specifically geared for the complexities of life science.
We aim to serve our clients, create a healthy and fun work environment, and assist with professional growth for everyone through customized career development plans. As a consultant working on multiple cross functional projects, you will be able to quickly garner a wide range of skills and areas of expertise that will propel your career progression.
If 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!
Ideal QualitiesIdeal candidates will exhibit, or have the willingness to develop, the following qualities:
- Strategic thinker with strong analytical skills who can translate client needs into actionable value-added projects/results.
- Willing to work hands on with multiple clients throughout California
- Ensures activities are efficient, optimized, and client centric.
- Highly motivated and organized, solutions-oriented leader.
- Curious and adaptable - has the ability to transform knowledge into actionable activities.
- Able to produce results in a fast paced, collaborative environment.
- Medical, Dental and Vision
- Competitive 401K plan
- Flexible Paid Vacation Time
- Employee Recognition Program
- Diversity and Inclusion Initiatives
- Training and Mentorship Opportunities
Learn more about who we are and what makes us great here: https://www.youtube.com/watch?v=9VmKkBLkoFQ