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ITM Isotope Technologies Munich SE
5d ago

Director, Early Development Regulatory Lead(m/w/x)

Garching bei München
Full-timeWith Home OfficeSenior

Description

As a regulatory expert, you will shape the radiopharmaceutical pipeline by leading global submission strategies and managing high-level interactions with the FDA and EMA.

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Requirements

  • •Degree in pharmacy, chemistry, biochemistry, biotechnology, or related field
  • •7–10 years of regulatory experience in pharma, biotech, or authorities
  • •Knowledge of pharmaceutical development and IND/CTA regulations
  • •Ability to integrate oncology drug regulations into development plans
  • •Experience in direct interactions with FDA and EMA
  • •Excellent English skills and optional German fluency

Education

Bachelor's degree
OR
Master's degree

Work Experience

7 - 10 years

Tasks

  • •Expertly lead early-stage radiopharmaceutical development projects
  • •Focus on upcoming IND and CTA submissions
  • •Report directly to the Head of Clinical Regulatory Affairs
  • •Act as primary contact for the FDA and EMA
  • •Manage regulatory interactions and operational submissions
  • •Collaborate closely with subject matter experts and project teams
  • •Lead scientific Health Authority meetings and protocol assistance
  • •Oversee timely filing of original and amendment INDs and CTAs
  • •Develop global regulatory strategies for product candidates
  • •Align regulatory plans with clinical development objectives
  • •Identify risks and implement mitigation strategies
  • •Coordinate high-quality responses to Health Authority requests
  • •Optimize submission strategies using appropriate regulatory pathways
  • •Review and approve clinical and non-clinical documents
  • •Author product-specific briefing books and regulatory reports
  • •Provide proactive guidance to clinical trial teams
  • •Stay current with evolving global regulatory guidelines
  • •Support business development and departmental initiatives

Tools & Technologies

IND regulationsCTA regulationsFDAEMA

Languages

English – Business Fluent

German – Business Fluent

Benefits

Flexible Working

  • •Hybrid working model
  • •Flexible working hours
  • •Home office options

Diverse Work

  • •Exciting challenges

Informal Culture

  • •Creative freedom
  • •Open working atmosphere
  • •International corporate culture
  • •Short communication channels

Learning & Development

  • •Comprehensive onboarding programme
  • •Individually tailored training programme
  • •German and English courses

Bonuses & Incentives

  • •Attractive special payments

Competitive Pay

  • •Employee participation programme

Company Bike

  • •Job bike

Public Transport Subsidies

  • •Subsidised job ticket

Retirement Plans

  • •Company pension scheme contribution

Healthcare & Fitness

  • •Health promotion programmes
  • •EGYM Wellpass
  • •Fitness studio subsidy

Team Events

  • •Sponsorship of sporting events

Mentorship & Coaching

  • •Lifestyle coaching sessions
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