• Regulatory advice to Pharmaceutical companies for the development of regulatory strategies to facilitate rapid development and registration of Chemicals and Biological products.• Specialised in Advance Therapy Products (cell and gene therapy): autologous and allogeneic cell therapy products, viral vectors (AAV), hospital exemption, etc.• Global regulatory expert (EU, FDA, Canada, etc) in the preparation and review of quality, nonclinical, safety and clinical documentation for use in regulatory filings.• Lecturer in Pharmaceutical Industry Masters, ESAME.

ALLADVICE is a Regulatory Affairs Consultancy – Created to support biopharmaceutical companies and public institutions, working with Advanced Therapy Medicinal Products (ATMPs) for human use, across all phases of the development, from non-clinical to post-marketing, to comply with regulatory requirements.https://alladvicepharma.com

• Preparing Regulatory Strategies for EU, US and Canada.• Manage and lead assigned regulatory projects including management of budget, timelines and submission planning in accordance with internal procedures and legislative requirements.• Coordinate Centralised marketing authorization applications in Europe. Lead dossier planning activities and liaison with contributing groups and external experts.• Leading clinical trial submission to EU countries and FDA.• Leading meetings with regulatory authorities

• Manage (prepare, review, compile and coordinate) regulatory activities to support registration and life-cycle management of approved products in EU and US.• Preparation and attendance to meetings with regulatory authorities, including preparation of background materials, logistical organization and writing meeting minutes.• Review of quality, nonclinical, safety and clinical documentation for use in regulatory filings.

• Responsible for the successful execution of CMC projects (new chemical entities) to obtain worldwide (EU centralised procedure, USA, Japan, Switzerland, etc) regulatory submissions/approvals and provide CMC support for established products.• Development of CMC regulatory strategies for new projects (clinical trials), leading preparation and regulatory compliance as required by company strategy.

• Development of Business plans and Regulatory Strategies to register CHEMO products (generics and new chemical entities) across the world: EU, USA, Asia (China, Vietnam, Philippines, Malaysia, Singapore, etc.), Central and South America (Brazil, Argentina, Paraguay, Guatemala, etc.), Mexico, Russia, Ukraine, Morocco, etc.• Interaction with all CHEMO subsidiaries and General Managers in the execution of regulatory strategies and drug registration activities to ensure the earliest possible product license approvals.

Preparation and writing up of regulatory sections (new chemical entities, biopharmaceutical company) of marketing authorisation applications and clinical trial applications (i.e. CTD, CTA, IND, IRD, miCTD, etc.); DMFs, ASMFs, Plant Master Files and other regulatory documents (Scientific Advice, Variations, Renewals, INN applications, etc.). These include compilation, analysis and evaluation of the information.

• Pharmaceutical assessment of applications for marketing authorisation (national, mutual recognition, decentralised, centralised) and variations (Type IB and Type II) for new chemical entities and generics.• Scientific and regulatory advice to companies.• Nominated EMEA expert.

Patient medication review, pharmaceutical advice, adverse events reporting, dispensary, aseptic production, cytotoxics, medicines information and mental health services. Promoting safe, effective and economical use of drugs