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CHCHEPLAPHARM Arzneimittel GmbH

Head of Regulatory Affairs(m/w/x)

Greifswald
Full-timeWith Home OfficeSenior

Leading regulatory activities for specialty pharma products with a 10-member product team at a global Specialty Pharma company. 10+ years Regulatory Affairs experience and initial leadership required. 30 days holiday, individually customizable working models.

Requirements

  • Degree in Natural Sciences, Pharmacy or Medicine
  • At least 10 years of professional experience in Regulatory Affairs
  • Initial leadership experience
  • Strong understanding of multidisciplinary functions across the pharmaceutical product lifecycle
  • Proven experience in development and leadership of regulatory strategies
  • High competence in managing complex interfaces and engaging with stakeholders
  • Cooperative and solution-oriented working approach
  • Confident communication and negotiation skills in German and English

Tasks

  • Lead regulatory activities for a product team of up to 10 members
  • Ensure compliance with national and international regulations
  • Develop and implement regulatory strategies aligned with company goals
  • Take responsibility for all regulatory processes within the team
  • Ensure timely execution and proactive risk management
  • Provide regulatory expertise to internal functions and project teams
  • Contribute to the optimization of regulatory processes and systems
  • Act as the Regulatory Affairs representative in cross-functional initiatives
  • Monitor and assess legislative and regulatory developments
  • Evaluate the impact of regulations on the business
  • Provide technical leadership and foster team development
  • Manage external service providers for quality and compliance

Work Experience

  • 10 years

Education

  • Bachelor's degree

Languages

  • GermanBusiness Fluent
  • EnglishBusiness Fluent

Benefits

Flexible Working

  • Individually customisable working models

More Vacation Days

  • Compensatory time off
  • 30 days of holiday

Additional Allowances

  • Flexible benefits budget
  • Subsidies for travel and meal costs

Healthcare & Fitness

  • Fitness and health offers

Corporate Discounts

  • Access to corporate benefits platform

Learning & Development

  • Internal and external training courses

Team Events

  • Company and team events
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