Nikol Sazanova

As an experienced professional with a background in pharmaceutical and biopharmaceutical industry and regulatory affairs, I have a deep understanding of the complex matrix of cGMP and regulations, including EU, FDA, EMA, and Health Canada. I am well-versed in working under ICH regulations and guidance, which has helped me develop excellent leadership, communication, and critical thinking/problem-solving capabilities.

With extensive experience working in leadership roles, I am comfortable working in collaborative and team working environments, as well as working alone. I am a focused and goal-oriented person who always puts the patient first, which is why I feel that the biopharma industry is so important. In addition, my attention to detail and focus on the right first-time approach when it comes to cGMP ensures that I am always working at the highest level of quality.

I am currently seeking a role that can leverage my experience and knowledge while allowing me to develop my personal career in a company that puts the patient at the center of everything it does. With a Master of Research in Oncology from the University of Manchester and a BSc (Hon) in Biomedical sciences from the University of Salford, I am well-equipped to tackle any challenge that comes my way.

My core skills include experience authoring regulatory documents, quality management systems, and validation studies. I have a strong understanding of process validation, as well as experience with FDS/EU submission. In addition, my strong interpersonal skills and negotiation skills have allowed me to interact effectively with regulatory authorities, and I have experience in clinical trial design, conduct, and analysis, statistical report production for trial results, and quality control management in vaccine/therapy manufacture using biotechnology.

Overall, I am a highly effective communicator with excellent critical thinking abilities and a track record of delivering results on time. I am confident that my skills and experience make me an excellent candidate for any role in the biopharma industry.