Meet the Expert: Mary Speagle

What is your role and what are your duties at Innomar Strategies?

I head up the regulatory affairs department supporting development of staff/areas of regulatory business and client services. Providing support to address regulatory strategy, Agency interface issues, regulatory filings.

What is the best part of your job? What do you find fascinating about it?

Solving difficult problems- pulling together challenging scientific/regulatory information and presenting in a cohesive manner, supporting clients/staff as they navigate challenging files/interface with Health Authority.

What is your superpower? What is your expertise in the pharmaceutical field?

My superpower is ability to review and analyze information presenting options and recommendations to move forwards. I am a generalist having spent time working with a variety of product types and therapeutic areas. My regulatory career was initially focused solely on medical devices. I expanded to cover OTC drugs, Natural Health Products and cosmetics. Currently I have been focused mainly on prescription drugs.

How do you foster a positive work environment within your team?

A positive work environment is fostered through frequent direct communications between management and consultants with forums such as weekly and monthly team meetings to share learnings and discuss issues. Staff are actively encouraged to share knowledge/process to efficiently develop client and internal workflow solutions.

How do you stay ahead of industry trends and collaborate with external partners?

Staying ahead of industry trends involves attendance at various industry conferences, review of new guidances/regulations as they come out, speaking engagements in the regulatory community. Collaboration with external partners involves joint projects, speaking engagements, provision of consulting services and other items as needed.

How do you integrate feedback into your work to continuously improve?

I ask direct reports as well as management for direct feedback on ways to improve support. Work is done with staff to develop and review processes.

What do you do when you are not working?

I spend time with my 4 daughters when I am not working. I also enjoy going to the gymn, reading and spending time with friends.

Mary Speagle is the Senior Director, Regulatory Affairs at Innomar Strategies, where she heads up a consulting team specializing in US and Canadian Regulatory Affairs. Mary’s broad experience covering 20 years in regulatory consulting includes both prescription and OTC drugs (Pharmaceuticals, Biologics, Natural Health Products), Medical Devices and Cosmetics. Mary has been working in the consulting area since 1998. Prior to joining Innomar Strategies, she headed up consulting teams at TPIreg and Mapi Life Sciences (previously OptumInsight and CanReg Inc.). She is a prior contributing author to the RAPS Essentials of Healthcare Product Labeling and Fundamentals of Canadian Regulatory Affairs. Mary served for many years on the CAPRA Board of Directors and the RAPS Editorial Board. Mary is an active member of numerous industry associations.

The information provided in this piece does not constitute legal or medical advice. Innomar Strategies Inc. and its parent Cencora, Inc. strongly encourage the audience to review available information related to the topics discussed to rely on their own experience and expertise in making decisions related thereto. Further, the contents of this piece are owned by Innomar Strategies, and reproduction is not permitted without the consent of Innomar Strategies.