Donnie Pulliam
Associate Director, Regulatory Affairs-CMC at Biogen
- Role
- Associate Director, Global Regulatory Affairs-cmc at Biogen
- Location
- Durham, NC, US
- LinkedIn followers
- 500 followers
About Donnie Pulliam
Project Manager and MBA with over 20 years of experience in the life sciences and biotechnology industries. Eager to apply both technical and managerial knowledge to broaden professional experience in business/product development, supply chain management and/or alliance management.
Experience
Associate Director, Global Regulatory Affairs-cmc
Apr 2022 — Present · Durham, NC, US
Lead development and implementation of regulatory CMC strategies for biopharmaceutical assets across the product development and lifecycle management continuum. Lead cross-portfolio initiatives in partnership with other regulatory affairs colleagues, Qualified Persons, and external supply chain partners to execute strategic and compliance-driven clinical trial application submissions and amendments. Plan and participate in global health authority engagement meetings to manage submission risks. Collaborate across industry via conferences/publications to influence the adoption of phase-appropriate science-based stability approaches during biopharmaceutical development and lifecycle management.
Education
North Carolina State University
BS, Chemical Engineering, Biosciences option
1992 — 1997
North Carolina State University - College of Management
MBA, Business
2009 — 2011
Southeastern Baptist Theological Seminary
Master of Arts - MA, Intercultural Studies
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