Maxime Wang

Global Regulatory Lead (via Aixial) @ Servier

About

With many years in local and international regulatory affairs, I have participated in several projects for Big Pharmas, but also for medium-sized companies and small biotech firms. Acted as a Regulatory Affairs Manager, I was responsible of the lifecycle of a portfolio of 28 products covering different therapeutic areas and acted as the first contact for the Health Authorities. I managed the Marketing Authorization and Renewal applications for radiological products in emerging countries (MEA, LATAM and APAC). Working with local specialists, I coordinated the creation of their submission dossiers. I also contributed to the submission of renewal applications at European level. Now responsible of the strategy and management of submissions of new marketing authorization in EU and outside of EU with very professionnal and experienced team.

Country

France

City

Greater Paris Metropolitan Region

Industry

Pharmaceuticals

Skill

Pharmacologie, Travail d'équipe, Recherche, Biologie moléculaire, Biochimie, Relations clients, Biologie cellulaire, Microsoft PowerPoint, Microsoft Office, FlowJo, Microsoft Excel, gestion de projet, R, CRF, Rédaction d’articles, Analyse de données, Saisie de données, Base de données, Conception bases de données, Gestion des données

Experience

Global Regulatory Lead (via Aixial)

Servier

2024-3 - Present · 2 yrs 7 mos

Greater Paris Metropolitan Region

Responsible for creation and execution of Global Regulatory Strategy and for the content of the dossier supporting registration and lifecycle management.

Regulatory Affairs Specialist

Stéarinerie Dubois

2023-5 - 2024-2 · 10 mos

Greater Paris Metropolitan Region

- Creation and maintenance of regulatory documentation (Product data sheet, Safety data sheet) - Support to clients questions - Product database management - Review and approval of new raw materials dossiers - Regulatory monitoring and support to other functions - Regulatory compliance of R&D products - Monitoring of quality compliance (ISO 9001, ISO 22000, ISO 14001 and BPF)

Regulatory Affairs Manager

PharmaLex

2022-1 - 2023-5 · 1 yr 5 mos

Greater Paris Metropolitan Region

In addition of previous responsibilities: * EU Regulatory Affairs Specialist - EU Renewal of a product registered in Centralized procedure - Ensure Module 1 conformity to submission requirements - Coordination of the procedure and experts For other clients : - Lifecycle management and support on local regulation - Marketing Authorization and « Exploitant » Transfert

Senior Regulatory Affairs Specialist

PharmaLex

2021-1 - 2021-12 · 1 yr

Greater Paris Metropolitan Region

For a client, a top 10 Big Pharma Company: * Senior Local Regulatory Affairs Manager - Lifecycle management of a complete and diverse French portfolio - French submission management (module 1, dossier approval) - Translation of the Product Information in French - Ensure Product Information conformity to approved annexes - Interaction with French Health Agency - Support to newer colleagues (training, mentoring) * International Manager - New and innovative cardiological product maintenance - Global support for international countries (excluding European Union, North America and Japan) for New Drug Application - Main support for Asian and African countries - Dossier preparation on Global side and delivery to affiliates

Regulatory Affairs Specialist

PharmaLex

2019-1 - 2021-1 · 2 yrs 1 mo

Greater Paris Metropolitan Region

For a client, a top 10 Big Pharma Company: * Local Regulatory Affairs Manager - Lifecycle management of a complete and diverse French portfolio * Established Product Manager - Mature radiological products maintenance - First contact for international countries (excluding European Union, North America and Japan) - Global support for New Drug Application and Renewal submission - Dossier preparation on Global side and delivery to affiliates

Project Coordinator and Assessor Trainee

ANSM Agence nationale de sécurité du médicament et des produits de santé

2018-2 - 2018-7 · 6 mos

Paris Area, France

Management of regulatory procedures for clinical trials amendments of health products - Technical and reglementary admissibility, and analysis of the application’s content - Assessment of the impact on patient’s safety - Coordination of specialized assessors - Follow-up of procedural milestones and meeting regulatory deadlines - Participation in the Temporary Specialist Scientific Commitee on the ranking of immunoglobilins’indications in a situation of hight supply problems and contribution to the preparation of a ministerial circular - Master’s thesis on the optimization of a multi-actors process