Freelancer profile translated to English.

Description

With 12 years of experience in International Regulatory Affairs, I have held positions in the pharmaceutical, medical device, and cosmetic industries. My expertise in cosmetic, pharmaceutical, and medical device regulations will enable you to develop and expand your cosmetic and medical products in the international market.

Industry field of expertise

Languages

French
Native or bilingual
English
Native or bilingual

Workplace preferences

Remote only

Primarily works remotely

Augustinus Bader
Cosmetic Regulatory Affairs Manager
April 2020 - December 2024 (4 years and 8 months)
Paris, France
• Drafting and preparation of registration, variation, and renewal dossiers for international markets for cosmetic products.
• Regulatory monitoring, preparation, compilation, and submission of regulatory documents for the registration and maintenance of existing and new products in these markets, respecting deadlines.
• Issuance of dossiers to LRAs in compliance with local constraints to avoid rejection by authorities, sending supplementary information to LRAs for dossier submission.
• Collaboration with supply chain, business coordinators, and logistics for the shipment of pharmaceutical products to international zones, participating in planning and deadlines.
• Collaboration with the NPD team for the management and change of packaging, participating in planning, meetings, and deadlines.
• Support for the development and management of the commercial offering, working with the sales director, providing support for product launches in legal and regulatory aspects.
• Identification of new international partners for the expansion and marketing of our products internationally.
• Prospecting, research, and selection of partners, relationship management (contact, meetings, phone calls, Webex meetings), sending and receiving project-related documents: confidentiality agreements, price and budget cost evaluations…etc.
• Providing methodological support (knowledge of the regulations of the concerned countries) to project stakeholders in conducting their activities and cross-functional communication.
• Responsible for developing relationships with distributors or local partners to understand and apply regulatory requirements for product registration and maintenance in different regions.
European Cosmetic Regulation Regulatory Affairs CPNP Notification Regulatory Watch PIF
Pfizer Global International Regulatory Affairs
Global International Regulatory Affairs - International Zone
November 2019 - April 2020 (5 months)
Île-de-France, France
• Preparation of submission documents for variation, renewal, and registration dossiers for emerging countries for medicinal products.
• Response to requests from regulatory authorities: technical documents, additional information regarding the proper use of the product.
• Management and request for translations, legalization of documents.
• Issuance of dossiers to LRAs in compliance with local constraints to avoid rejection by authorities, sending supplementary information to LRAs for dossier submission.
• Support to manufacturing sites and GRA collaborators, sending GMP documents, Manufacturing license, declarations, CPPs.
• Electronic and DHL submission to local contacts and foreign subsidiaries.
• Post-submission update of the dossier in the CST SharePoint.
Regulatory Affairs Project Management Team Management Regulatory Watch Regulatory Compliance
Alliance Pharma
International Regulatory Affairs Manager - ASIA Zone
January 2017 - November 2019 (2 years and 10 months)
Paris, France
• Drafting and preparation of variation, renewal, and registration dossiers for the Asian zone for medical devices, cosmetics, and medicinal products.
• Regulatory monitoring, preparation, compilation, and submission of regulatory documents for the registration and maintenance of existing and new products in these markets, respecting deadlines.
• Response to requests from regulatory authorities: technical documents, additional information regarding the proper use of the product.
• Anticipation of regulatory changes to incorporate necessary changes for new requirements into the development process.
• Review and validation of promotional materials and product packaging in accordance with applicable regulations and in coordination with distributors.
• Responsible for developing relationships with distributors or local partners to understand and apply regulatory requirements for product registration and maintenance in different regions.
• Collaboration with supply chain, business coordinators, and logistics for the shipment of pharmaceutical products to the Asian region, participating in planning and deadlines.
• Support for the development and management of the commercial offering, working with the sales director, providing support for product launches in legal and regulatory aspects.
ISO 13485 MDR 2017/745 QMS ISO 14971 CE Marking MD