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Senior Director Regulatory Affairs and Product Safety

Get to know our colleague Hadley!

Años de experiencia profesional

11

Years of professional experience:

País

United States

Country

Parte de la familia Merz Therapeutics desde

2014

Part of the #MerzTxFamily since

We are surrounded by people who are passionate and dedicated to their “customer,” whether that is a patient, a healthcare provider, or another employee.

Hadley, Senior Director Regulatory Affairs and Product Safety

  1. Oversee regulatory operations for the U.S. and Canada, including regulatory strategy and maintenance as well as advertising and promotional review
  2. Responsible for drug safety and pharmacovigilance for U.S. products

I started as an intern in the U.S. Research & Development team in the Greensboro, NC office in 2014. After my internship, I was hired as a Regulatory Affairs Specialist and was promoted to Senior Specialist and then Manager, Regulatory Affairs. During this time, I had responsibilities with the development, maintenance, advertising, and promotion of many different drugs, biological, over-the-counter, and cosmetic products. In 2020 with our transition to Merz Therapeutics, I assumed responsibility for not only the Therapeutics U.S. Regulatory Affairs team, but also Regulatory Operations and Drug Safety and Pharmacovigilance. At the beginning of 2021, my team also took over Regulatory Affairs and Operations for Canada and in July I was promoted to Senior Director, Regulatory Affairs and Product Safety.

The most important parts of my job are obtaining approval for new indications that serve more patients and ensuring the safety of our products for all that patients use them. The most important document for both of those objectives is the prescribing information. Whereas most people think of it as the huge, thin sheet of paper with small font that comes in the packaging for their medicines, it conveys important information about the safety and efficacy of our products and controls the level of access to necessary treatments for patients. Every time I think about the strategy for a new indication to potentially allow access to a new or broader patient population, I get to envision a better outcome for more patients.

When you’re working with regulatory authorities, there is no expectation that your day will end up the way you planned it. Usually, I’m participating in study team meetings discussing our ongoing or future clinical trials for new indications, reviewing submission documents for a meeting with FDA or an application for a new indication, signing off on advertising and promotional materials, or meeting with my team members. However, if we get a call or an email from FDA or Health Canada requesting information, that takes the highest priority until we have a plan to address their request!

Because Merz is over 110 years old and still privately owned by the same founding family, there is a feeling of longevity and stability that I don’t think you feel at other companies. When the COVID-19 crisis began, leadership reminded us that Merz had survived two world wars and the Great Depression by focusing on its people and its patients. I feel very fortunate to work at Merz, particularly during the last year and a half, because I know that they aren’t making short-term decisions based on quarterly results, but instead are looking at what they need to do to be around for generations to come.

At Merz Therapeutics, you are surrounded by people who are passionate, compassionate, and dedicated to their “customer,” whether that is a patient, a physician, or another Merz employee. I often feel that everyone around me is trying to move in the same direction, towards the same objective, which is ultimately trying to provide better outcomes for more patients. This means that there is less drama, less emphasis on the small issues, and more of a feeling of working together as a team. Merz Therapeutics employees take our company values and operating norms very seriously, and I see and feel people embodying them every day.

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