JOB DESCRIPTION

Position 
Job title: Regulatory Affairs Manager
Department: Clinical 
Location: Berlin or Würzburg (Germany)

Company

PentixaPharm is a young radiopharmaceutical company with a small agile team of highly qualified employees committed to develop the innovative theranostic pair PentixaFor and PentixaTher specifically targeting the CXCR4-receptor expressed in most fast progressing diseases such as hematological and solid cancers as well as cardiovascular malignancies.

Purpose of the Position

  • Responsibility for all Regulatory Affairs issues within the scope of the respective development projects.
  • Responsibility for the preparation of the submission documentation in conformity with the regulatory guidelines (EU and Non EU).
  • Implement the up to date internal and external regulatory guidance and process; deliver milestones within time, resources and cost agreed by the company.

Main Responsibilities and Tasks 

  • Leading the regulatory strategy for clinical product development in collaboration with internal functions and, potentially, also external consultants
  • Advising development functions on the planning of health authority interactions during the product development process
  • Writing and coordinating high-quality regulatory documents for submission to health authorities in collaboration with the individual functions (e.g., CTA and IND, briefing books, NDA dossiers)
  • Preparing and participating in health authority interactions such as scientific advice or pre-IND meetings
  • Monitoring compliance with regulatory requirements and schedules
  • Responding to deficiency letters from health authorities
  • Supporting due diligence and partnering activities
  • Identifying new regulatory requirements through ongoing further training
  • Incorporating new regulatory developments in the development strategy and internal work processes, including drawing up and revising work instructions in collaboration with the relevant functions

Experience / Qualifications

  • Ideal: Qualification/degree and significant Industry expertise in regulatory affairs
    • Degree in Pharmacy, Pharmacology, Biochemistry, Chemistry, medicine or any other relevant disciplines
  • Minimum: 3-4 years of professional experience with regulatory affairs with the health authorities at national and international level, or in the pharmaceutical industry, including knowledge of licensing requirements and legislation

    • In depth knowledge and understanding of European, US and other international regulations as well as the ability to assess regulatory risks/benefits and applicable guidance
    • Experience in preparing and coordinating preclinical and clinical documents for submission to the health authorities (e.g., CTA, IND, scientific advice briefing books, etc.)
    • Proven track record in the area of radiopharmaceuticals, diagnostics and oncological drugs
  • Languages: Fluent English and German

Required Competencies

  • Solid understanding of generic drug development process, ICH guidelines, local and regional regulatory with ability to interpret and apply policies
  • Good knowledge of Microsoft Office suit
  • Leadership / Willingness to lead, take charge, and offer opinions and recommendations especially with regards to working in multidisciplinary teams in a complex global environment
  • Innovation / being proactive, creative and demonstrating alternative thinking to develop new ideas and solve problems quickly

Other Useful Information

  • Specifics of the position: multi-disciplinary international project management
  • Internal and external contacts (organisation): yes, with about 20% traveling
  • People management:  managing diverse relationships
  • Benefits:
    • Performance Bonus
    • 30 days of vacation
    • Exciting job opportunity with project responsibilities and freedom for professional growths and acquisition of new skills

If you want to become a part of our young and motivated team and if you are ready for a new challenge, we are looking forward to your complete application including your salary expectations - please send it to: hakim.bouterfa@pentixapharm.com.

We are looking forward to receiving your application!