The company
I am currently working with a dynamic 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!
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