Director of Regulatory Affairs
2 weeks ago
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
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