A Drug Regulatory Specialist serves as a key liaison between product developers and regulatory authorities, ensuring that therapeutic products comply with all applicable laws and guidelines. Their role involves compiling and submitting comprehensive documentation required for regulatory approvals, such as Investigational New Drug (IND) applications, New Drug Applications (NDA), and Marketing Authorization Applications (MAA). They carefully interpret complex regulatory requirements from agencies worldwide and provide strategic advice to align product development activities accordingly. By managing timelines and coordinating cross-functional teams, these specialists help streamline the approval process and minimize regulatory risks. Their work ensures that products meet the highest standards for safety, efficacy, and quality before reaching patients.
Beyond submissions, Drug Regulatory Specialists continuously monitor changes in regulations and guidance documents to ensure ongoing compliance throughout a product’s lifecycle. They assist in preparing responses to regulatory queries, supporting inspections and audits, and updating product information when necessary. Their expertise in navigating the global regulatory environment supports successful product launches and market access. This role demands strong communication skills, attention to detail, and the ability to adapt to evolving regulatory frameworks. Ultimately, their contributions are vital in bringing safe and effective treatments to patients while maintaining the integrity of the regulatory process.
Title : Ectopically expressed olfactory receptors as an untapped family of drug targets and discovery of agonists and antagonists of OR51E1, an understudied G protein-coupled receptor
Vladlen Slepak, University of Miami Miller School of Medicine, United States
Title : Managing healthcare transformation towards personalized, preventive, predictive, participative precision medicine ecosystems
Bernd Blobel, University of Regensburg, Germany
Title : Analytical strategies for solid-state forms in drug development
Maria Cristina Gamberini, University of Modena e Reggio Emilia, Italy
Title : Understanding drug transport in plasma: The role of protein binding
Saad Tayyab, UCSI University, Malaysia
Title : Innovative development and delivery of biologics for chronic obstructive pulmonary disease
Yong Xiao Wang, Albany Medical College, United States
Title : Search for novel biomarkers and therapeutic targets for inflammatory disease
Madhav Bhatia, University of Otago, New Zealand
Title : Personalized and Precision Medicine (PPM) as a unique healthcare model through de-sign-inspired biotech- & biopharma-driven applications and upgraded business mar-keting to secure the human healthcare and biosafety
Sergey Suchkov, N.D. Zelinskii Institute for Organic Chemistry of the Russian Academy of Sciences & InMedStar, Russian Federation
Title : Design and evaluation of exo-itc: A bilayer fibrous system for controlled exosome delivery in dermatological applications
Luis Jesus Villarreal Gomez, FCITEC - Universidad AutĂłnoma de Baja California, Mexico
Title : Abuse-deterrent dosage form technique utilizing a fusion of innovative pharmaceuticals and ion exchange resin
Bhupendra Gopalbhai Prajapati, Parul University, India
Title : Macitentan/tadalafil combination– An additional value in pharmacotherapy of pulmonary arterial hypertension
Miroslav Radenkovic, University of Belgrade, Serbia