David Batka

David has extensive regulatory affairs experience with chemical and biological prescription medicines, medical devices and in-vitro diagnostic (IVD) devices in the APAC region.
With a technical and manufacturing expert background, David has utilised his skills facilitating the registration and maintenance of the full range of device risk classifications including immunohematology IVDs. David has successfully managed several new TGA conformity assessment applications and new device registrations and is equally experienced in post-market vigilance activities.

David also has a technical and CMC expert background and gained in-depth API knowledge while working on numerous Drug Master Files and CEPs. David has utilised his skills in the preparation of regulatory submission strategies and dossiers for many product registrations and complex variations. More recently, David has successfully managed several new product registrations via the international ACCESS work-sharing and the Comparable Overseas Regulator (COR) reliance pathways.

Over the years David has established solid knowledge of the full spectrum of registration maintenance activities, including GMP clearances, he has provided strategic advice to numerous global cross functional teams.

In his current role at Adjutor, David enjoys reviewing complex cases to provide expert regulatory advice and strategy for clients. He is a scientist at heart and is passionate about sharing his knowledge while learning about new technologies, supporting existing client relationships and building new connections.

David brings to the team a strong background of technical skills, knowledge, analytical thinking, and proven negotiation skills as regulatory liaison with agencies and key-stakeholders across the globe.