Director Global Regulatory Operations 

Elaine Ogunbiyi

With over 30 years Regulatory Affairs experience, Elaine is an expert in the development of solid regulatory submission strategies, plans, systems, and processes, all critical to meet clients’ needs for regulatory documents preparation and submissions. This role covers investigational, marketing, and other application types essential to meeting global clients’ needs and regulatory agencies requirements.  Her extensive experience runs across all stages of product development, regulatory review, approval, launch and life cycle management.

Key areas of expertise
  • Specialist in managing submissions strategies, planning of global regulatory submissions, systems development, and processes
  • Extensive leadership in working with cross functional teams, global partners, and clients to develop integrated development plans to support new, pending, approved and marketing applications
  • In-depth knowledge of eCTD and other regulatory requirements essential to supporting global regulatory applications and submissions
  • Highly skilled in labelling operations, labelling components mock-ups, final printed labelling, structured product labelling (SPL) and readiness for launch
  • Solid management and training experience to support the development of global regulatory staff
  • Extensive experience in working with Safety Reporting and PV teams to ensure compliant safety reporting and FDA inspections
Before NDA

Elaine established and headed up Regulatory Affairs Operations and Labeling teams at large, medium, and small Pharma companies where she excelled in working on numerous global application types (IND, NDA, ANDA, MAA, NDS, ODD, DMFs, IDE, 510(k)s) to support regulatory approvals. She has acquired extensive experience in liaising with cross functional teams, global sites, and third-party partners, to develop regulatory systems and integrated development plans in support of new, pending, approved and marketing applications. She has supported and executing numerous integrated plans for timely responses to Regulatory Agency Information Requests and life cycle management to support product development, approval, and marketing.

Elaine is passionate about participating in new regulatory agency initiatives such as pilot programs, eCTD submissions, electronic systems, and Labeling User Groups to ensure that her regulatory knowledge is always up to date.

Elaine Ogunbiyi

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