Victor Paulus - Episode 14 - Regulatory Voices

Kicking off series 3, next week on Regulatory Voices, I sit down with Victor Paulus Ph.D, a senior regulatory leader with more than 30 years of experience across vaccines, women’s health, biologics and radiopharmaceuticals.Victor has had a fascinating route into Regulatory Affairs, beginning his career in the laboratory and vaccine manufacturing before making the move into Regulatory and eventually leading functions across multiple organisations.In this episode, we discuss:How moving from manufacturing into Regulatory completely changed the way Victor thought about the FDA.Why understanding regulation is very different from simply knowing or memorising it, and the importance of becoming comfortable operating in the grey areas.The role mentorship played throughout his career, and why finding someone you can genuinely accept criticism from can be so valuable.Whether something has been lost as more people enter Regulatory directly, rather than bringing experience from CMC, manufacturing, clinical or other functions.Why Victor increasingly values regulatory generalists, particularly within smaller biotech companies.And finally, we explore radiopharmaceuticals, an area Victor describes as one of the best career moves he ever made, including the regulatory, manufacturing, safety and logistical challenges that make the space so unique.A wide ranging and easy going conversation covering career development, FDA interactions, judgment, mentorship, leadership and an increasingly important area of drug development.Tuesday 29th September, 8am ET, Live in LinkedIn, available same day on Spotify, YouTube and Apple Podcasts.Brought to you by Codon Partners, Life Science Staffing.