Felicia A. Bullock, MBA

Felicia A. Bullock, MBA

Felicia A. Bullock, MBA

Director

Felicia is a Regulatory Affairs professional with 25 years of CMC and Quality Systems experience in the pharmaceutical industry including development activities for US INDs, NDAs and ANDAs through the approval process and including post marketing application management. Felicia has directed large and small cross-functional teams to deliver highquality on-time dossier submissions, regulatory responses, and achieve approvals for commercial marketing of drug products.

Felicia has prepared the CMC sections for submissions and agency briefing packages, attended FDA meetings, and secured approvals for a wide variety of small molecule drug products in various therapeutic areas including topical creams and ointments, antibiotics, parenteral and IV additive products, ophthalmic, and solid oral dosage forms. Felicia has also conducted due diligence exercises and risk assessment activities related to strategic drug product portfolio acquisitions. She is an exceptional communicator able to assist clients in the development of regulatory and commercial operational strategies to achieve their company objectives.

Work Experience

At Parexel, Felicia is a line manager for US Principal Consultants and actively facilitates client relationship building while providing technical leadership within projects. Prior to joining Parexel, Felicia held senior leadership positions in Regulatory Affairs in the pharmaceutical industry as Senior Director, CMC with Glenmark Pharmaceuticals, Senior Director and Department Head with Luitpold Pharmaceuticals, Senior Director CMC with Fougera (Sandoz) Pharmaceuticals and Senior Director Regulatory Affairs with King Pharmaceuticals. Prior to her career in Regulatory Affairs, Felicia’s career in the pharmaceutical industry began as an analytical chemist in analytical R&D with Wyeth Consumer Healthcare, where she developed and validated methodology for the formulation evaluation and testing of new drug products.

Education

Felicia holds a bachelor’s degree in Chemistry and Biology from Mary Baldwin College, and a MBA from Averett University.

We are always available for a conversation.

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