Adhil H. Email & Phone Number

Dubai, United Arab Emirates

Dubai, United Arab Emirates

• Managed Lifecycle for pharmaceutical and cosmetic products in GCC, ensuring compliance with local standards.• Oversaw registration process for semi-controlled and non-controlled drugs, including variations and site-related activities.• Facilitated authorization and permits for imports and exports of conventional, vet, and cosmetic products.• Prepared and validated dossiers in various formats such as CTD, VNeeS, and eCTD.

Greater Bengaluru Area

- Transition of CTD to CTR.- CESP submission for MRP, NP,DCP, - Provided support from IND to NDA submissions for EU.- Primary and Ad-Hoc in studies submission- Production of high-quality dossiers by handling the collection of components, publishing /assembly, quality review, and delivery of submissions in paper and electronic format (like NeeS, eCTD. etc.).- completion of Modules 1-5 in eCTD format, compilation of NeeS, compilation of paper submission, publishing and validation.-Preparing and assembling applications (INDs, NDAs, ANDAs, DMFs, variations, routine reports, renewals etc.) for submission to EMA.

United Kingdom

• Led regulatory submission for AI enabled SaMD and Medical Device- 510k, PMA, DeNovo- Ensuring market access and compliance with regulatory requirements:- -Device Classification and Regulatory Pathway,-AI Software Validation and Compliance - Provide documentation that the AI system is validated for safety, accuracy, and effectiveness.• Clinical Trial and Preclinical Support:- Provided regulatory oversight for the design and execution of preclinical studies (e.g., biocompatibility, animal studies) and clinical trials to ensure the device meets regulatory requirements• Cybersecurity and Risk Management- Ensure compliance with the FDA’s cybersecurity requirements for AI systems, especially when data is transmitted or stored remotely (e.g., cloud-based systems or SaMD's).• Managed change control and submissions for software changes, supporting architectural changes in the Software Domain.Supported projects :-Ai enabled Prenatal Ultrasound Scanning Device.Ai enabled Cardiac Device (Novel).

United Arab Emirates

Getinge is a global MedTech company manufacturing Medical Devices, and Life Science products.- My main roles includes CAPA, FSCA, document management, complaint handling, etc.- Manage Safety Actions and Compliance: Complaint System, GMP, and recalls for regulatory compliance.- Auditor and Regulatory Inspections: Conducts internal audits, and facilitate external audits/regulatory inspections.- Global RA Projects: Actively participate in global RA initiatives.- Regulatory Intelligence and Market Access: Maintain regulatory surveillance, and support medical device registrations.- Collaboration with Functional Areas: Provide RA input/support.- Collaborated across departments for dossier submissions.- Ensure Regulatory Compliance.- SaMD - Regulations and Compliances.

Bengaluru, Karnataka, India

Master'S Degree, Regulatory Affairs, 9.4 Cgpa

Global Regulatory Affairs, RA Intelligence, Ai and Ml in MD's and Pharma Cosmetics,

Bachelor Of Pharmacy - Bpharm