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Smiling employee in a conversation with a colleague in the office
Smiling employee in a conversation with a colleague in the office
ID: 103851

Regulatory Affairs Manager

  • Pharma & Biotech
  • Asap
  • Generics OTC Drugs, Fragrance, Cosmetics
  • K-Recruiting GmbH
Contact:

Julius Strack

+49 89 1890998-614

julius.strack@k-recruiting.com

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

  • 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

Extract from previous activities

2022 – 2024

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

2019 – 2021

Pharmaceutical Company, Algeria / Remote

Regular Affairs Manager

  • Regulatory Affairs Consulting

  • Documentation

  • Packaging and Labeling

2017 – 2018

Pharmaceutical Company, Austria

Regular Affairs Manager

  • Natural cosmetics factory

  • Submissions and labeling of cosmetics

2006 – 2011

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

2005 – 2006

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)