This conversation is part of Arazy Group Consultants’ Regulatory Rockstar Movement, which I was invited to participate in last month.
In the world of regulatory affairs, where rules and protocols reign supreme, there exists a luminary whose journey defies the conventional norms. Meet Michelle Lott, a formidable force in the realm of regulatory affairs. In a candid conversation, Michelle shares insights into her professional journey, peppered with anecdotes that unveil her unique blend of expertise, resilience, and wit.
Michelle’s entry into regulatory affairs wasn’t a predetermined path but rather a serendipitous discovery. She recalled that “it was something that kind of found [her].” With a background in forensic toxicology and retail management through her dad’s wholesale rug business, she embarked on her regulatory journey almost by chance. After moving to North Mississippi and applying for a job at Baxter Healthcare, she was thinking of going back to her laboratory roots.
Joining Baxter Healthcare marked a pivotal moment in Michelle’s career. Initially hired for an internal auditor role, she seamlessly combined her technical acumen with interpersonal skills honed through years of retail management. Michelle remembered, “They left a stack of regulations on my desk…” and she figured out her first audit from there.
Michelle reflected on the pivotal role her mentor played in shaping her early career at Baxter. Despite being inexperienced in auditing and regulatory environments, Michelle’s mentor recognized and nurtured her talents, instilling the confidence she needed to thrive. This support not only helped Michelle overcome her doubts but also solidified her understanding of her capabilities.
Driven by an entrepreneurial spirit, Michelle eventually established her own regulatory strategy consultancy, leanRAQA, which has grown to a team of ten over the last 13 years.
“I’m a third generation entrepreneur. So I feel like it was always kind of in my DNA to start my own business. […] We don’t fit well in the box that other people create for us. What drives me is to be the one that creates the environment and have the opportunity to help other people where they’re at.”
Specializing in assisting startups and small to mid-sized companies, Michelle’s approach transcends traditional consulting paradigms. “We’re collaborators…we stay involved with our clients, ideally from concept development into commercialization, supporting along the way” she explains.
What sets Michelle apart as a leader is her innate ability to empathize and empower those around her. “It’s all about making other people successful,” she affirms. Whether navigating regulatory intricacies or mentoring budding professionals, Michelle’s leadership style revolves around meeting people where they are and facilitating their growth.
Michelle’s journey wasn’t without its share of challenges. Throughout her career and personal life, she encountered significant hurdles that made her feel as though she was trapped in a “pressure cooker.” However, these trials served as invaluable opportunities for growth, pushing her to navigate adversities and acquire knowledge at an accelerated pace. Embracing confidence in her innate talents and capabilities ultimately propelled her towards success, yet she continually found herself needing to reaffirm her abilities to herself.
“Every time I’ve grown in my career, I was my biggest obstacle at each stage. […] I think that is the biggest challenge for women. We don’t give ourselves enough credit.”
Michelle is challenging regulatory affairs with her unconventional and creative approach. Unlike traditionalists who see regulations in black and white, Michelle navigates the gray areas with finesse, considering broader contexts and interpreting regulations through multiple lenses. In the first technical file she ever wrote, she remembers it as a “creative writing exercise” and telling a true story about the product. Her perspective challenges the notion that compliance is solely about rigid adherence to rules, highlighting instead the importance of innovative problem-solving and creativity while ensuring patient safety remains paramount.
Beyond her professional endeavors, Michelle’s passion for education and advocacy shines brightly. As a lecturer and educator at schools such as Galway Medical Institute and John Hopkins, she imparts knowledge and fosters dialogue, transcending conventional boundaries. “I love educating and speaking… I come from a long line of teachers,” she reflects. Michelle finds profound satisfaction in meticulously crafting course materials, each research endeavor reinforcing her sense of belonging and inspiring her to innovate in the ways she conveys information.
Outside her career, Michelle finds solace in the company of her husband and 3 furry rescued companions. Although she travels frequently for work, she loves to spend time by the coast. On the weekend, you can find her enjoying an unconventional Eggs Benny at her favorite place in Tucson, or watching a comedy movie!
With an infectious sense of humor and a zest for life, Michelle embodies resilience, compassion, and authenticity.
Link to the original Regulatory Rockstar blog, written by Arazy’s Isabel Tansey: https://blog.arazygroup.com/regulatory-rockstar-blog/michelle-lott
