Director, Regulatory Affairs

Salary: £180000 to £999999
Contact name: Selina Maini

Contact email: selina.maini@medella.life
Job ref: 366
Published: 15 days ago

The company

I am currently working with a biotech company who are dedicated to the development, production and global supply of targeted diagnostic and therapeutic radiopharmaceuticals and radioisotopes for use in cancer treatment. They are seeking a Director, Regulatory Affairs based within the USA to join their dynamic team! This is a full-time permanent position with remote work available. 

Key responsibilities:

  • Serve as the main point of contact with FDA for the company’s products portfolio
  • Assure use of appropriate regulatory procedures to secure the optimum FDA submission strategy and lifecycle management of complex theragnostic radiopharmaceutical products
  • Determine from a strategic and scientific perspective the appropriate content and write/review high quality product-specific documents for FDA submissions (e.g. briefing books, iPSPs, DMFs, INDs/NDAs, etc.). Ensure that these documents meet high scientific standards and regulatory requirements and are optimized to US specific aspects
  • Participate in product-related discussions and provide strategic, scientific and regulatory input for FDA-specific aspects at all development stages on CMC, nonclinical, clinical, labeling and/or procedural aspects.
  • Ensure planning and proper organization of US activities in line with the overall project plan and RA milestones, identify risks and mitigation strategies
  • Provide advertising and promotional expertise to US commercial team
  • Stay current with changes in regulatory guidelines and rules, understand and communicate their impact on regulatory strategy for the particular assets; advise project teams on how best to address changes

What we are looking for:

  • Life science degree
  • Ability to work in a hierarchically flat, matrix environment
  • Minimum 7 years of regulatory and drug/biologic development experience, ideally in oncology indication
  • Experience with radiopharmaceuticals will be an asset
  • Experience as liaison with US FDA
  • Experience in both clinical and CMC regulatory affairs
  • Experience in IND and NDA regulations and US regulations pertinent to product development
  • Good management, interpersonal, communication, negotiation and problem solving skills
  • Ability to work independently, team player

What we offer:

  • A modern workplace and exciting opportunities in an evolving and fast growing company
  • Challenging and varied projects in interdisciplinary, multicultural and highly professional teams
  • A collegial corporate culture and short communication channels
  • Flexible working hours with an attractive salary package and diverse corporate benefits