Job Description

Meet is working with a pre-IPO biotech in the rare disease space looking to hire a Director of Regulatory Affairs!

Requirements:

• A degree in life science, chemistry, chemical engineering, or a closely related discipline (graduate degree preferred), with at least 10 years of experience in biotechnology/pharmaceutical regulatory affairs. Experience in a fast-paced, small company environment & Hematology Oncology/Oncology experience is preferred.
• Proven track record of drafting, reviewing, and finalizing successful regulatory submissions (e.g., IND/CTA, NDA/BLA/MAA), with direct experience in pharmaceutical regulatory submissions and product approvals. Strong knowledge of FDA regulations, ICH guidance, and global health authority practices across the US and Europe (UK experience is a plus).
• Strong proficiency in MS Word, Excel, PowerPoint, Visio, Adobe Acrobat, and document formatting templates. Excellent verbal, written, negotiation, and interpersonal communication skills, with the ability to engage effectively with internal teams and external audiences at all levels.
• Demonstrated ability to manage multiple complex projects, prioritize workloads, and adapt to changing circumstances. Proven leadership in managing regulatory activities and leading cross-functional teams. Ability to work independently and influence others, with prior management experience a plus.
• Experience providing strategic advice on integrated regulatory development plans and lifecycle management. Strong collaborative, analytical, and interpretative skills to review and compile reports and documents for regulatory submissions.
• Extensive experience leading regulatory agency interactions, with a focus on successful management and communication with global regulatory bodies.

Please apply directly if your experience aligns!

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