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Director, US Regulatory Lead (f/m/d)

About ITM

ITM is a privately owned biotechnology and radiopharmaceutical group of companies dedicated to the development, production and global supply of targeted diagnostic and therapeutic radiopharmaceuticals and radioisotopes for use in cancer treatment. We are developing a proprietary portfolio and growing pipeline of targeted treatments in various stages of clinical development addressing cancers such as neuroendocrine cancers or bone metastases. Our main objectives are to significantly improve treatment outcomes and quality of life for cancer patients through a new generation of Targeted Radionuclide Therapies in Precision Oncology. The headquarters are located in the heart of the research center of the Technical University of Munich (TUM).
We would like to fill the following permanent vacancy in a remote-based or hybrid working model as soon as possible

Director, US Regulatory Lead (f/m/d)

Your role

  • Act as Regulatory Affairs representative and expert for US regulatory requirements for early and/or late-stage development projects within the radiopharmaceutical pipeline, with prime focus on upcoming NDA submission(s)
  • Act as regulatory contact point vis-a-vis FDA for ITM Inc., US Responsible for regulatory interactions and submissions to the FDA, with operational accountability for upcoming NDA filing(s)leveraging the input from the subject matter experts and global regulatory team at ITM
  • Provide clear and valid US specific regulatory guidance to the product core teams, interpretation by applying ‘out of the box thinking’ mind set, at all development stages on CMC, nonclinical, clinical, labeling and/or procedural aspects
  • Lead the preparation and conduct of FDA meetings (Pre-IND, Pre-NDA, Type A-D)
  • Ensure planning and proper organization of US activities in line with the overall global project plan and regulatory milestones, including identifying risks and mitigation strategies
  • Oversee coordination, preparation and timely submission and approval of original and variation filings (e.g., INDs, NDAs) for US on the assigned products/projects, working in a global collaborative manner
  • Ensure use of appropriate regulatory procedures to secure the optimum FDA submission strategy and lifecycle management of complex radiopharmaceutical products
  • Write and review high quality product-specific documents for FDA submissions (e.g., meeting requests, briefing books, iPSPs, orphan annual reports etc.), as needed. Ensure that these documents meet high scientific standards and regulatory requirements and are optimized to US specific aspects
  • Collaborate with Cross-Functional departments in particular such as clinical, regulatory, marketing, and US commercial team

Your profile

  • Successfully completed scientific studies (Bachelor/Master) in pharmacy, chemistry, biochemistry, biotechnology or related field. Post-graduate degree is of advantage
  • A minimum of 10 years in Regulatory role(s) and used to working independentlyProfound knowledge of regulatory requirements related to pharmaceuticals. Profound experience from direct interactions with FDA
  • Experience with radiopharmaceuticals will be an asset
  • Experience as liaison with US FDA. Experience in IND and NDA regulations and US regulations pertinent to product development and registration
  • Ability to work as a team player and independently
  • Assertiveness, methodical competence, ability to work in a team and reliability
  • Good management, interpersonal, communication, negotiation and problem‑solving skills

Our offer

  • Exciting challenges in an up-and-coming and fast-growing company with a high degree of creative freedom
  • An open working atmosphere in an international corporate culture with short communication channels
  • Comprehensive onboarding programme
  • Flexible working hours with home office options
  • Attractive special payments
  • Just a good salary? Not with us! We also offer you Employee participation programme
  • Individually tailored further training programme (including German and English courses)
  • Health promotion programmes

Do you have these qualifications, are you willing to develop yourself further and are you looking forward to becoming a key part of our future? Great! We should get to know each other!
When you apply, please let us know your earliest possible starting date and your salary expectations. You can submit your CV in German and English in docx or pdf format.

Contact

Nadine Sürken
+49 89 329 8986 -1709
career@itm-radiopharma.com

ITM Isotope Technologies Munich SE
Human Resources
Walther-von-Dyck-Str. 4
85748 Garching/München, Deutschland

Note for recruitment agencies
Please note that we do not accept unsolicited applications or offers of assistance. The telephone number given in the advertisement is intended exclusively for applicants and should not be contacted for any other purpose. Thank you very much!

More about ITM

With us, you will have the opportunity to work in an international environment on ground-breaking projects that can have a significant impact on cancer care worldwide. We are looking for dedicated, talented and passionate professionals who share our vision and want to help shape the future of oncology. If this exciting challenge appeals to you and you would like to contribute to realising our common goal, please do not hesitate to send us your application. We look forward to hearing from you!
For more information please visit: www.itm-radiopharma.com

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Director, US Regulatory Lead (f/m/d)

ITM Isotope Technologies Munich SE
München
Unbefristet, Vollzeit

Veröffentlicht am 22.02.2025

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