Head of RA

Posted 04 January 2023
LocationMaxhütte-Haidhof
Job type Permanent
Reference76215
Contact NameDavid Skinner

Job description

Head of Regulatory Affairs f/m/d

Your Responsibilities
 
  • Develop regulatory strategies for Marketing Authorization Applications and subsequent maintenance activities of development products in EU and US, including the development of pediatric development plans.
  • Be an expert in international regulatory aspects to effectively support all other units of the company.
  • Represent the Regulatory Affairs Department during Agency inspections and meetings with external partners or scientific key opinion leaders.
  • Provide regulatory input to strategic development plans and clinical investigation plans.
  • Monitor changes in regulatory laws and regulations and evaluate the impact on the pharmaceutical industry in general and on the business in particular.
  • Develop active networks for the Regulatory Affairs Department with internal and external stakeholders.
  • Manage and ensure contractual agreements with external providers for regulatory services.
  • Act as a contact and escalation point for regulatory matters, identify internal needs for training and new/changed procedures, as well as develop solutions to address knowledge gaps within the organization.
  • Plan and control the financial budget for the regulatory affairs activities
  • Ensure relevant regulatory SOP’s are developed and implemented to effectively support the needs of the business.

Your Profile
 
  • Master´s Degree or PHD advanced degree in appropriate scientific discipline
  • Minimum 5+ years of global regulatory experience in drug development and life-cycle management
  • Prior experience leading health authority interactions; experience leading or supporting major submissions from filing through approval
  • Demonstrated leadership capabilities and ability to think strategically
  • Demonstrated ability to integrate regulatory science with scientific/clinical knowledge
  • Demonstrated track record of working in a multifunctional matrix biotech environment
  • Experience in managing multiple projects and proactively plan
  • Experience of all phases of the drug development process in Regulatory Affairs would be a plus
  • Experience in working with strategic partners/cross company collaborations
  • Experience in partnering with business development in due diligence efforts
  • Excellent communication skills in English and German
  • High level of commitment, flexibility & perseverance