Over 20 years of in-depth experience as Regulatory Affair Specialist
Accomplished over 3 projects with focus on fragrance and cosmetics, also on the DACH region
Excellent experience as international project manager, with experience on global level (Europe, Middle East, Asia)
We got to know this specialist as knowledgeable empathetic and highly professional. This consultant has already delivered a 2-year project via K-Recruiting
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Our content and services may vary by location.
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Overview
- Availability
- Asap, 5 days/week, on-site & remote
- Qualification
- Master of Pharmacy
- Language Skills
- German, French & Arabic (native), English (business fluent)
- Relevant Expertise
- Expertise: Regulatory Affairs, Fragrance, Cosmetics, Labelling, Food Supplements, Generics OTC Drugs, RX Drugs, Life Cycle Management, Pharmacovigilance, Medical Devices, Pharma
Key-Facts
Extract from previous activities
Pharmaceutical Company, Germany (via K-Recruiting)
Regulatory Affairs Manager Food Supplements (FSMP)
Development of notification/registration strategies for food supplements in EU and Non-EU countries
Preparation of needed documents and dossiers and submission to authorities and partners
Responses to authority questions and updating of submission documentation
Support of external stakeholders regarding approval procedures
Fragrance and Cosmetics
Pharmaceutical Company, Algeria / Remote
Regular Affairs Manager
Regulatory Affairs Consulting
Documentation
Packaging and Labeling
Pharmaceutical Company, Austria
Regular Affairs Manager
Natural cosmetics factory
Submissions and labeling of cosmetics
Pharmaceutical Company, Austria
Head of Regulatory Affairs, Deputy QPPV, Authorised signatory
OTC, Generics, Herbals, Rx
Responsibility for Building the Regulatory Affairs and Pharmacovigilance Department (total 4 employees)
Preparation and coordination of DCP & MRP procedures, having Pharma select as applicant and marketing authorization holder, and Austria as Reference Member State
Compilation of CTD dossiers (CMC, clinical, preclinical), reformatting of NTA into CTD
Building the Regulatory network in Austria, Germany, Greece, Australia, Eastern European Countries, Russia & CIS countries
Strong relationship and lobbing with the Austrian Health authorities (AGES) and other EU authorities
Responsibility for building a Document Management System as well as an e-CTD software solution
Pharmaceutical Company, Austria
Regulatory Affairs Specialist
Life Cycle Management, Bio surgery & Vaccines
Preparation of documentation for licensing purposes for EU countries, follow-up on marketing applications and on licensed products (MRP & centralized procedure), North American (FDAUSA), and Intercontinental region (LATAM, Asia)
Coordination of change control procedures
Establishment of direct contacts with regulatory authorities (world-wide)