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Smiling employee in a conversation with a colleague in the office
ID: 137644

Senior Regulatory Affairs Manager

  • Pharma & Biotech
  • Asap
  • Regulatory Strategies, Management of CCDS
  • K-Recruiting GmbH
Contact:

Julius Strack

+49 89 1890998-614

julius.strack@k-recruiting.com

Overview

Availability
Asap, 0,5 FTE, onsite & remote
Qualification
Master of Drug Regulatory Affairs, Master of Pharmaceutical Biotechnology
Language Skills
German (native), English (business fluent)
Relevant Expertise
Regulatory Affairs Management, Submission Management (National & Global), Product Development, Life Cycle Management, Regulatory Strategies, Dossier Preparation, Management of CCDS, Rare Diseases, Orphan Drug Designations

Key-Facts

  • Regulatory Affairs Expert with 8+ years of experience, specializing in rare diseases, geographic expansion, and European regulatory procedures

  • Successfully led regulatory submissions across 15+ countries and guided products through development and lifecycle management with a focus on efficiency and global alignment

  • Global regulatory strategy, dossier management, cross-functional collaboration, and project leadership

Extract from previous activities

Pharmaceutical Company, Germany

Senior Global Regulatory Manager

  • Directed regulatory strategy, tactical execution, and global submissions for assigned projects, with a focus on rare disease products

  • Led new application procedures in over 15 countries, including EU, Switzerland, South Korea, Australia, Mexico, Taiwan, and regions across the Middle East, ensuring alignment with regional regulatory requirements

  • Prepared and managed regulatory dossiers, including PIP submissions, scientific advice meetings, and orphan drug designations

  • Leading the creation and maintenance of the Company Core Data Sheet

  • Delivered regulatory intelligence, identifying and communicating emerging trends with potential business impact, fostering alignment with strategic goals

  • Acted as a key liaison between R&D, Franchise, and Commercial Operations to facilitate cross-functional collaboration on regulatory matters

Pharmaceutical Company, Germany

Global Regulatory Manager

  • Directed regulatory strategy, tactical execution, and global submissions for assigned projects, with a focus on rare disease products

  • Led new application procedures in EU, Switzerland, UK and Australia ensuring alignment with regional regulatory requirements

  • Contributed to US regulatory procedures, collaborating with the lead team to ensure alignment with FDA requirements and regulatory strategy

  • Prepared and managed regulatory dossiers, including PIP submissions, scientific advice meetings, and orphan drug designations

  • Leading the creation and maintenance of the Company Core Data Sheet

  • Acted as a key liaison between R&D, Franchise, and Commercial Operations to facilitate cross-functional collaboration on regulatory matters

  • Managed regional regulatory intelligence initiatives and contributed to global strategies for product compliance

Pharmaceutical Company, Germany

Regulatory Affairs Manager DACH

  • Led regulatory activities for national procedures, overseeing Module 1 preparation and submission processes to ensure alignment with global regulatory strategies

  • Acted as the primary contact for health authorities in Austria, Germany, and Switzerland, managing authority requests and facilitating communication to support compliance and timely approvals

  • Represented the regulatory department in cross-functional teams, ensuring regulatory requirements were met throughout product lifecycle management as well as new application procedures

  • Collaborated with global teams to support market entry and maintenance activities, streamlining processes and aligning strategies with business objectives

Pharmaceutical Company, Germany

Regulatory Affairs Manager

  • Spearheaded the preparation, coordination, and submission of DCP/MRP and national regulatory procedures, ensuring compliance and timely responses to regulatory authorities

  • Conducted comprehensive deficiency management for new applications and lifecycle management

  • Assessed and implemented Change Control measures to maintain dossier compliance, particularly for Module 1 and Module 3-related changes

  • Coordinated with European national authorities, contract manufacturers, and internal teams, providing regulatory support and guidance to ensure successful submissions