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Merz Therapeutics
last mo.

Team Lead Regulatory Affairs Regions(m/w/x)

Frankfurt am Main
Full-timeWith Home OfficeSenior

Description

As the Team Lead for Regulatory Affairs, you will guide a dedicated team in ensuring compliance and optimizing processes throughout the product lifecycle. Your role involves collaborating with global teams, managing regulatory submissions, and assessing opportunities to enhance organizational success.

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Requirements

  • University degree in natural sciences, preferably pharmacy, biology, chemistry, or equivalent
  • 10+ years in regulatory affairs or pharmaceutical industry
  • 5+ years of line management experience in global pharmaceutical industry
  • Comprehensive knowledge of international regulatory environment and frameworks
  • Experience in project management and budget control
  • Analytical and strategic thinking with compliance and quality mindset
  • Solution-oriented team player with strong negotiation skills
  • Excellent communication skills in English, German is a plus

Education

Bachelor's degree

Work Experience

10 years

Tasks

  • Lead a regional regulatory affairs team
  • Ensure compliance with regulatory requirements
  • Drive performance and optimize regulatory processes
  • Provide local input for global submissions
  • Respond to authority requests in collaboration with global teams
  • Maintain licenses and update milestones for global reporting
  • Align regional input with global strategy
  • Coordinate key interactions with regulatory authorities
  • Assess regional risks and opportunities for product acquisitions
  • Support departmental goals and process improvement

Languages

EnglishBusiness Fluent

GermanBasic

Benefits

Competitive Pay

  • Attractive remuneration

Other Benefits

  • Extensive social benefits
  • Attractive location

Career Advancement

  • Individual career development

Flexible Working

  • Hybrid work model

Family Support

  • Good work-life balance

Parking & Commuter Benefits

  • Good transport links

Modern Office

  • Modern workplaces

Free or Subsidized Food

  • Company restaurant

Informal Culture

  • Flat hierarchies
  • Open corporate culture

Additional Allowances

  • Employer-subsidized benefits

Healthcare & Fitness

  • WellPass

Public Transport Subsidies

  • Deutschland-Ticket

Corporate Discounts

  • Corporate Benefits

Company Bike

  • JobBike
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