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Director of Regulatory Affairs

2 months ago

boston, United States Blackfield Associates Full time

Blackfield Associates is exclusively partnered with a clinical stage biotech company that is pioneering in the development and approval of rare disease innovative treatments. We are looking to hire a Director, Regulatory Affairs to lead the US regulatory strategy firsthand.



Regulatory Director Key Responsibilities:


  • Provide strategic and operational leadership in regulatory affairs, including regulatory strategies, clinical study requirements, and marketing approvals in various regions.
  • Be the point of contact for FDA/ regulatory authorities, as subject matter expert
  • Review sections of IND/CTA, BLA/MAA, and other global submission documents in support of clinical trials and marketing applications.
  • Oversee the preparation and submission of documentation for global investigational and marketing registration, ensuring compliance with local regulations.
  • Engage with global regulatory authorities to resolve issues and expedite fillings
  • Monitor and assess the global regulatory landscape to inform business and product development strategies.
  • Collaborate with senior stakeholders across functions to align regulatory strategies with business goals internationally.


Required Qualification and Experience:


  • Ph.D. with over 10 years of experience in pharmaceutical regulatory affairs, of relevant experience in biotech or pharmaceutical industries.
  • Experience in leading regulatory affairs in clinical development, phase 2 and phase 3 studies
  • Extensive experience with INDs/CTAs, BLAs, MAAs, lifecycle management, interactions with Regulatory Agencies, leading and managing regulatory teams
  • Strong interpersonal, with the ability to work effectively in a global, cross-functional lead business
  • Therapeutic area experience: Solid tumours, with an emphasis on rare disease designation
  • This is a hands-on position; candidates must be proactive, hands-on leaders
  • Essential: Proven FDA experience, from leading communication, to overseeing major fillings and approvals