Title: SVP, Head of Global Research and Development and Regulatory Affairs
A West Virginia native, Andrea Miller started with Mylan in 1989, when it was “a little bit smaller." She joined as a clinical research associate when Mylan only operated in the U.S., and in the years to come, her career would grow as she helped the company dramatically extend its footprint.
Throughout her career, in roles spanning research, regulatory and operations, Miller said she “developed a very strong interest in regulatory affairs." At Mylan, she’s had the opportunity to pursue that passion: throughout her nearly-three-decade career at the drugmaker, she’s spent about half of her time in regulatory positions, she said in an interview.
Miller has played an important role as Mylan pushed to build out its respiratory and biosimilar offerings and complete a global expansion into markets around the world. Mylan now markets medicines in more than 165 countries, she said.
Miller’s responsibilities at the company grew significantly when Mylan went global in 2007 through a merger with Merck KGaA's generics arm. With the move, Miller took the position of global regulatory head for Mylan.
One of the “most fulfilling parts” of the position—and in her life—was getting to travel, learn about different cultures and meet with experts from all over, she said. Now, the company has 47 facilities located worldwide.
These days, Miller serves as Mylan’s global head of R&D and regulatory affairs, managing a staff of 3,000 experts working on projects in injectables, solid oral drugs, topical transdermals and more. She views her position as an “enabler,” saying she believes she works for her employees and is responsible for helping them perform their best. That’s a stance Mylan CEO Heather Bresch has taken with her own role, Miller said.
Before her current position, Miller played an important role in Mylan’s push into biosims in recent years. The company now has four biosim approvals—for copies of Sanofi's Lantus, Roche’s Herceptin, Amgen’s Neulasta and AbbVie’s Humira. Miller said those approvals are among the proudest moments in her career.
Throughout her career, she’s learned that the “biggest challenge you face is yourself.” It’s important to “weather the good and the bad” in pharma, she says, as failures in the field are inevitable. Instead of running from mistakes, she believes it's best to face them directly.
Even as she has spent decades at one company, Miller doesn’t feel she’s missed out on any learning opportunities. She said she’s been able to learn from other experts who have joined the company and brought a wealth of knowledge from their own unique experiences.