Heather Faulds

SVP, Regulatory Affairs & Knowledge Management Services at Alkermes

Heather Faulds was named senior vice president and Head of Regulatory Affairs & Knowledge Management Services in June 2020. In this role, Ms. Faulds is responsible for providing regulatory oversight and strategic development for both development candidates and commercial products. Ms. Faulds leads Regulatory Strategy, Advertising & Promotion, Regulatory Operations, CMC Regulatory, and Knowledge Management Services, and is responsible for overseeing the developmental regulatory approval and post-approval processes, including post-approval regulatory support for marketing activities and interfacing with alliance partners. Ms. Faulds reports into Craig Hopkinson, Executive Vice President, Research and Development and CMO of Alkermes, and sits on the company’s Executive Management Committee.

Ms. Faulds has more than 20 years of experience leading global regulatory strategies across all phases of development, as well as multiple disease areas and therapeutic modalities. Prior to joining Alkermes, she was SVP, Regulatory Sciences and Quality at Scholar Rock where she led multiple functions spanning Regulatory Affairs, GxP Compliance, Pharmacovigilance, and Medical Writing and was responsible for regulatory strategies across clinical programs for rare diseases and immuno-oncology. Prior to joining Scholar Rock, Ms. Faulds spent 12 years at Biogen in roles of increasing responsibility across CMC Regulatory and Global Regulatory Strategy. While there, her leadership paved the way for the expedited and unprecedented global regulatory submissions and approval of the first treatment for spinal muscular atrophy.

Ms. Faulds earned a bachelor’s degree in Biology from the University at Albany, SUNY and holds a Master of Regulatory Affairs and Health Policy from the Massachusetts College of Pharmacy.

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Timeline

  • SVP, Regulatory Affairs & Knowledge Management Services

    Current role

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