Immatics N.V.
Associate Director Regulatory Affairs – Clinical Lead*(m/w/x)
Full-timeWith HomeofficeSenior
München
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ITITM Isotope Technologies Munich SE
Director, Early Development Regulatory Lead(m/w/x)
Garching bei München
Full-timeWith Home OfficeSenior
Nejo AI Summary
Leading projects for radiopharmaceuticals in cancer treatment, focusing on IND/CTA submissions and FDA/EMA interactions. 7-10 years experience with pharma/biotech submissions and health authority interactions, including direct FDA/EMA, required. Flexible hybrid work options.
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
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
Work Experience
- 7 - 10 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
- German – Business Fluent
Tools & Technologies
- IND regulations
- CTA regulations
- FDA
- EMA
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
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of ITM Isotope Technologies Munich SE and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
Not a perfect match?
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Head of Early Pipeline Strategy(m/w/x)
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ITITM Isotope Technologies Munich SE
Director, Early Development Regulatory Lead(m/w/x)
Garching bei München
Full-timeWith Home OfficeSenior
Nejo AI Summary
Leading projects for radiopharmaceuticals in cancer treatment, focusing on IND/CTA submissions and FDA/EMA interactions. 7-10 years experience with pharma/biotech submissions and health authority interactions, including direct FDA/EMA, required. Flexible hybrid work options.
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
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
Work Experience
- 7 - 10 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
- German – Business Fluent
Tools & Technologies
- IND regulations
- CTA regulations
- FDA
- EMA
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
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of ITM Isotope Technologies Munich SE and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
About the Company
ITM Isotope Technologies Munich SE
Industry
Pharmaceuticals
Description
Das Unternehmen entwickelt, produziert und vertreibt zielgerichtete diagnostische und therapeutische Radiopharmazeutika sowie Radioisotope für die Krebsbehandlung.
Not a perfect match?
- Immatics N.V.
Associate Director Regulatory Affairs – Clinical Lead*(m/w/x)
Full-timeWith HomeofficeSeniorMünchen - Alnylam Pharmaceuticals, Inc.
Associate Director, Regulatory Affairs(m/w/x)
Full-timeWith HomeofficeSeniorMünchen - ITM Isotope Technologies Munich SE
Medical Affairs Manager(m/w/x)
Full-timeWith HomeofficeExperiencedGarching bei München - ITM Isotope Technologies Munich SE
Head of Early Pipeline Strategy(m/w/x)
Full-timeWith HomeofficeManagementMünchen - Immatics Biotechnologies GmbH
Director Clinical Sciences(m/w/x)
Full-time/Part-timeWith HomeofficeManagementTübingen, München