Donna Lonesky, MBA

Donna Lonesky, BSc, MBA, has over 25 years of experience supporting clients with strategic and effective presentation of CMC data to global regulatory authorities. She has an exceptional understanding of CMC content for new drug registrations, amendments, annual notifications, and post-approval lifecycle management in ICH CTD format.

Donna also has a proven track record working in a cGMP pharmaceutical environment, supporting corporate compliance and quality initiatives, including change control management and inspection support.

As Director of CMC Regulatory Affairs, Donna provides CMC guidance through each phase of product development (IND/IMPD), new registrations (BLA/NDA), and post-marketing lifecycle management to ensure compliance with global requirements. She frequently collaborates and builds positive working relationships with area subject matter experts (SMEs) to ensure dossier submission quality, develop and implement strategies, and respond to authority information requests. Donna has extensive knowledge of biological drug products and proven experience authoring global CMC (Modules 2 and 3) submission documents for compliance with ICH eCTD requirements.

Before joining Syner-G, Donna was a SME who prepared technical dossier information and routinely responded to regulatory information requests in support of global submission strategies. She collaborated with corporate regulatory counterparts at other sites, both domestically and internationally, to determine regulatory requirements and coordinate submissions to enable successful regulatory reviews. During this time, she was responsible for the regulatory management of CMC changes for thirteen licensed biological products, including new registrations, variations, post-marketing commitments, periodic reports, and technical transfers. While Donna’s experience focused on the U.S. and Canada as primary markets, she also provided CMC support for secondary markets in the European Union (MRP, Decentralized and National), Latin America, Asia Pacific, and the Middle East. Donna has proven experience managing overlapping and aggressive timelines.

Donna received her Bachelor of Science in Biology from the University of Illinois, her Master of Business Administration from Olivet Nazarene University (Bourbonnais, IL), and an Associate in Science from Parkland Community College (Champaign, IL).