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Senior Regulatory Affairs Specialist Germany - Job Opportunity at Galderma Laboratories GmbH

Düsseldorf, Germany
Full-time
Senior
Posted: April 27, 2025
Hybrid
EUR 75,000 - 95,000 annually based on location and seniority level in German pharmaceutical sector

Benefits

Market-competitive compensation package with performance bonus
Flexible hybrid work arrangement with generous home office policy
30 days annual leave plus additional flexible days
Employer-funded pension plan
Comprehensive wellness program including fresh fruit and beverages
Lunch voucher program for office days
International project opportunities
Employee recognition program

Key Responsibilities

Lead strategic regulatory management for pharmaceutical products in German market
Develop and implement regulatory strategy for new and marketed pharmaceuticals
Navigate complex interactions with health authorities
Ensure compliance and timely updates of product licenses
Monitor and adapt to regulatory developments
Provide backup support for medical devices and cosmetics regulation

Requirements

Education

Pharmacy degree, Natural Sciences degree, or Bachelor's/Master's in Pharmaceutical Sciences or equivalent qualification

Experience

3-5 years in pharmaceutical regulatory affairs

Required Skills

Excellent knowledge of German & European pharmaceutical legislation Understanding of medical device and cosmetic regulations Deep pharmaceutical industry knowledge Experience with Medical Affairs collaboration Stakeholder management and negotiation skills Comprehensive GxP and SOP knowledge
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Industry Trends

Increasing regulatory complexity in EU pharmaceutical landscape requiring specialized expertise Growing convergence of pharmaceutical, medical device, and cosmetic regulations creating need for broader regulatory knowledge Rising importance of digital health solutions affecting regulatory frameworks Heightened focus on post-market surveillance and safety monitoring

Role Significance

Typically part of a 5-8 person regulatory affairs team in mid-sized pharmaceutical organizations
Strategic position with direct impact on product market access and business growth in German market

Key Projects

New product registration strategies Regulatory compliance programs Health authority negotiations Cross-functional product development support

Success Factors

Deep understanding of evolving European regulatory landscape Strong stakeholder management abilities across multiple regulatory domains Strategic thinking combined with technical expertise Ability to navigate complex regulatory frameworks while maintaining business objectives

Market Demand

High demand due to expanding regulatory requirements and limited talent pool with combined pharmaceutical and medical device expertise

Important Skills

Critical Skills

Pharmaceutical regulatory expertise with special focus on German market requirements Strategic thinking and stakeholder management Cross-functional collaboration abilities

Beneficial Skills

Medical device and cosmetics regulatory knowledge Digital health regulatory understanding International regulatory experience

Unique Aspects

Rare combination of pharmaceutical and aesthetics industry exposure
Opportunity to work across multiple regulatory frameworks
Strong focus on dermatology specialty market
Global reach with local regulatory importance

Career Growth

2-4 years in role before advancement opportunity, depending on business growth and performance

Potential Next Roles

Head of Regulatory Affairs Regional Regulatory Director Regulatory Policy Director Global Regulatory Strategy Lead

Company Overview

Galderma Laboratories GmbH

Global dermatology leader focused on aesthetic injections, dermocosmetics, and therapeutic solutions

Leading specialized dermatology company present in 90 countries
Strong European presence with significant German market operations
Innovation-driven environment with focus on scientific excellence and professional development
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