In this article, we shine the spotlight on Michael Cooper, Senior Consultant at NDA.


A winding path to making a positive change in the world

Michael Cooper, Senior Consultant at NDA Group, is passionate about making a difference in the world, whether through technical work or directly supporting the patients. He paints a picture of his winding career path to regulatory affairs from a background in chemical engineering to his current role at NDA.

With a degree in chemical engineering, supplemented by electives in biomedical engineering, Michael applied his technical skills and knowledge in different fields. By working in different roles within the oil and gas, chemical, and nuclear industries, he gained valuable experience in process safety and risk management.

“While conducting studies to prevent catastrophic accidents and documenting them for government review, I realized how much I enjoyed technical writing. The idea of combining technical writing and science for a greater purpose resonated with me on multiple levels.”

Michael felt like he wanted to contribute more to society, so he decided to transition to healthcare. He says, “I got into biopharma as a validation engineer, focusing on facilities, utilities, and equipment validation.” While he recognizes the important role that effective manufacturing processes and systems play in developing high quality medicines, he also wanted to learn about how the actual products are made, released, and distributed to patients.

Seeking to broaden his expertise, Michael moved into quality assurance at a company manufacturing biologic products and vaccine. He reflects on a milestone where he was involved in a project to enhance efficiency in drug product batch release processes. He worked on a team that developed a more efficient process that helped streamline procedures and reduce batch release time from six months to 40 days. This shift to quality assurance marked a significant step towards Michael’s decision to specialise in regulatory affairs.

Getting closer to the patients

“I had always been interested in regulatory affairs because other than making the medicine itself, getting the approval is as close as you can get to making a difference in the lives of patients. As a former boss told me, ‘In regulatory affairs, we take the fantastic development work that the very smart scientists do, and we help them tell the story to the regulators so that they can get approval.’ We're not out there discovering the molecules and testing them, but we’re helping it get over the finish line.”

Michael is skilled at preparing CMC applications and agency responses to CMC information requests. His core strengths include describing manufacturing processes and simplifying complex procedures, making them easy to understand for regulators. As a Senior Consultant at NDA, he uses these skills on diverse projects where he is involved in authoring marketing application sections and conducting gap assessments. “I enjoy the diversity of projects,” Michael shares, “ranging from obtaining clearance for investigational products in clinical trials to seeking marketing approval for more mature products. Every project brings new challenges and opportunities to learn and grow. I am motivated to share the lessons I've learned from previous projects, and hopefully, they can help clients encountering similar challenges to get approval or clearance faster.”

This passion for sharing knowledge and guiding clients through the regulatory processes is what drives Michael's dedication to his work. He enjoys working in teams, in collaboration with other colleagues, which is one of the reasons why he was inspired to join NDA. In his words, “Thanks to the collaborative atmosphere and vast expertise, you never feel like you're on your own. When I encounter a challenge and I'm unsure how to tackle it, I can always turn to my colleagues for support and bounce ideas off them.”

Alongside his work, Michael uses music and travel to recharge and find balance. “I play the guitar and sing in our church choir and with an interfaith choir. I also enjoy travelling with my family,” he shares. Michael is eager to explore more destinations with his family, viewing it as an exciting opportunity to create lasting memories.

Everything falls into place

Michael's career growth from quality assurance to his current role has been a series of stepping stones, each one contributing to his expertise.

“My career path has been a progression. My background in validation and quality assurance exposed my interest in helping get drugs approved. When I first got into regulatory affairs, I worked on post-approval lifecycle maintenance, which gave me insight into document writing and revision. These experiences helped me handle products in earlier stages of development, giving me a full view of the product's life cycle as I work on regulatory CMC.”

Reflecting on his career growth of about 25 years, Michael shares invaluable advice he would offer his younger self—a perspective that could be useful to aspiring professionals.

“If I could advise my younger self, I would say dive in, gain experience, and work hard. Show that you're making a difference, and opportunities will present themselves. If you have an end goal in mind, such as regulatory affairs, take courses and certifications to prepare yourself. It is important to start gaining experience early, as it can be leveraged into future opportunities.”

About

Michael Cooper

Senior Consultant

Read more

Stay up to date

Contact us

Your drug development needs are unique

Contact us to learn how our experts can support you to meet all regulatory, quality and safety requirements and ensure the best path to approval.

Let's Bring Medicines to the World

  • This field is for validation purposes and should be left unchanged.