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
Senior Manager, Early Development Regulatory Lead(m/w/x)
Garching bei München
Full-timeWith Home OfficeSenior
Nejo AI Summary
Regulatory expert for early-stage radiopharmaceutical development, focusing on IND/CTA submissions and direct FDA/EMA interactions. Profound knowledge of oncology drug development regulations required. Flexible working hours, home office options, and employee participation programme.
Requirements
- Completed Bachelor's or Master's degree in pharmacy, chemistry, biochemistry, biotechnology, or related field; post-graduate degree is an advantage
- Profound knowledge and hands-on experience with regulatory requirements for pharmaceutical development, with a strong focus on IND and CTA regulations applicable to clinical development
- Ability to understand, interpret, and strategically integrate oncology drug development regulations and guidelines into comprehensive development plans; experience with radiopharmaceuticals is a strong asset
- Experience in direct interactions with regulatory authorities, particularly FDA and EMA
- Excellent written and spoken English skills; fluency in German is a plus
Tasks
- Serve as Regulatory Affairs expert for early-stage development projects
- Focus on upcoming IND/CTA submissions
- Report directly to the Head of Clinical Regulatory Affairs
- Act as primary regulatory contact with key Health Authorities (FDA, EMA)
- Hold operational accountability for regulatory interactions and submissions
- Collaborate closely with subject matter experts and the Global Project Team
- Lead preparation and conduct of scientific Health Authority meetings
- Oversee timely preparation, submission, and approval of filings (INDs, CTAs)
- Develop and implement global regulatory strategies for product candidates
- Align strategies with clinical development plans and program objectives
- Plan, organize, and manage regulatory activities
- Identify and mitigate risks for complex radiopharmaceutical products
- Coordinate timely, high-quality responses to Health Authority requests
- Optimize submission strategies using appropriate regulatory pathways
- Provide regulatory input, review, and approval of key documents
- Review and approve study protocols, Investigator’s Brochure, and reports
- Author and review high-quality, product-specific regulatory documents
- Collaborate with cross-functional experts on regulatory documents
- Ensure compliance with regional regulatory requirements
- Provide proactive regulatory guidance to clinical trial teams
- Maintain strong cross-functional stakeholder collaboration
- Stay current with evolving regulatory guidelines
- Support non-program-specific initiatives (e.g., business development, training)
Work Experience
- 7 - 10 years
Education
- Master's degree
Languages
- English – Business Fluent
- German – is a plus
Benefits
Flexible Working
- Flexible working hours
- Home office options
Bonuses & Incentives
- Attractive special payments
Competitive Pay
- Employee participation programme
Company Bike
- Job bike
Public Transport Subsidies
- Subsidised job ticket
Retirement Plans
- Above-average company pension scheme contribution
Learning & Development
- Individually tailored further training programme
- German courses
- English courses
Healthcare & Fitness
- Health promotion programmes
- EGYM Wellpass
- Subsidy for local fitness studio
Social Impact
- 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.
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ITITM Isotope Technologies Munich SE
Senior Manager, Early Development Regulatory Lead(m/w/x)
Garching bei München
Full-timeWith Home OfficeSenior
Nejo AI Summary
Regulatory expert for early-stage radiopharmaceutical development, focusing on IND/CTA submissions and direct FDA/EMA interactions. Profound knowledge of oncology drug development regulations required. Flexible working hours, home office options, and employee participation programme.
Requirements
- Completed Bachelor's or Master's degree in pharmacy, chemistry, biochemistry, biotechnology, or related field; post-graduate degree is an advantage
- Profound knowledge and hands-on experience with regulatory requirements for pharmaceutical development, with a strong focus on IND and CTA regulations applicable to clinical development
- Ability to understand, interpret, and strategically integrate oncology drug development regulations and guidelines into comprehensive development plans; experience with radiopharmaceuticals is a strong asset
- Experience in direct interactions with regulatory authorities, particularly FDA and EMA
- Excellent written and spoken English skills; fluency in German is a plus
Tasks
- Serve as Regulatory Affairs expert for early-stage development projects
- Focus on upcoming IND/CTA submissions
- Report directly to the Head of Clinical Regulatory Affairs
- Act as primary regulatory contact with key Health Authorities (FDA, EMA)
- Hold operational accountability for regulatory interactions and submissions
- Collaborate closely with subject matter experts and the Global Project Team
- Lead preparation and conduct of scientific Health Authority meetings
- Oversee timely preparation, submission, and approval of filings (INDs, CTAs)
- Develop and implement global regulatory strategies for product candidates
- Align strategies with clinical development plans and program objectives
- Plan, organize, and manage regulatory activities
- Identify and mitigate risks for complex radiopharmaceutical products
- Coordinate timely, high-quality responses to Health Authority requests
- Optimize submission strategies using appropriate regulatory pathways
- Provide regulatory input, review, and approval of key documents
- Review and approve study protocols, Investigator’s Brochure, and reports
- Author and review high-quality, product-specific regulatory documents
- Collaborate with cross-functional experts on regulatory documents
- Ensure compliance with regional regulatory requirements
- Provide proactive regulatory guidance to clinical trial teams
- Maintain strong cross-functional stakeholder collaboration
- Stay current with evolving regulatory guidelines
- Support non-program-specific initiatives (e.g., business development, training)
Work Experience
- 7 - 10 years
Education
- Master's degree
Languages
- English – Business Fluent
- German – is a plus
Benefits
Flexible Working
- Flexible working hours
- Home office options
Bonuses & Incentives
- Attractive special payments
Competitive Pay
- Employee participation programme
Company Bike
- Job bike
Public Transport Subsidies
- Subsidised job ticket
Retirement Plans
- Above-average company pension scheme contribution
Learning & Development
- Individually tailored further training programme
- German courses
- English courses
Healthcare & Fitness
- Health promotion programmes
- EGYM Wellpass
- Subsidy for local fitness studio
Social Impact
- 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.
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
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 - Immatics N.V.
Associate Director Regulatory Affairs – CMC Lead(m/w/x)
Full-timeWith HomeofficeManagementMünchen - Immatics N.V.
Manager Regulatory Affairs – Submission Lead(m/w/x)
Full-timeWith HomeofficeExperiencedMünchen - Denk Pharma GmbH & Co. KG
Teamlead Regulatory Affairs EU/Germany(m/w/x)
Full-timeWith HomeofficeSeniorMünchen - Denk Pharma GmbH & Co. KG
Manager Regulatory Affairs für Deutschland & die EU(m/w/x)
Full-timeWith HomeofficeExperiencedMünchen