Director, Regulatory Affairs

Taylor Strategy Partners; United States; Remote; USD 180,000 - 240,000; Full time

Job summary

Taylor Strategy Partners is seeking a Director/Senior Director, Regulatory Affairs to lead global regulatory strategy and submissions. The role involves ownership of major components of global submissions and agency engagement across US, EU, UK, and Japan.

Ideal candidates have 10+ years in regulatory affairs within biopharma, with proven NDA and MAA submission leadership and strong experience with EU regulatory activities for rare diseases.

Qualifications

• BS in Biology, Chemistry or related discipline.
• 10+ years of regulatory affairs experience in biopharmaceutical industry.
• Proven success leading global NDA and MAA submissions.
• Deep expertise with MAA submissions.
• Experience managing EU regulatory activities for rare diseases.
• Global regulatory leadership experience in US/EU/UK/Japan.

Responsibilities

• Develop and execute global regulatory strategy for US, EU, UK, and Japan.
• Lead interactions with regulatory authorities across regions.
• Prepare, author, and review major regulatory submissions (NDA, MAA, JNDA).
• Engage with FDA, EMA, and PMDA as needed.
• Collaborate with external consultants and regional agencies to deliver high-quality deliverables.

Skills

Global regulatory strategy

NDA submissions

MAA submissions

FDA/EMA/PMDA interactions

Education

BS in Biology or related discipline

Tools

IRAS Combined Review system

Job description

Description

About the Role

Late clinical‑stage rare disease company preparing for NDA & global submissions and commercial readiness is seeking a Director/Senior Director, Regulatory Affairs to join as their second regulatory hire. Reporting to the VP of Regulatory Affairs, this individual will play a critical leadership role in shaping and executing global regulatory strategy across the US, EU, UK, and Japan.

This is an execution‑oriented and strategic position ideal for someone who thrives in small biotech environment and has successfully led global submissions for rare disease medicines. You will partner closely with the VP while owning major components of global strategy, submissions, and agency engagement.

Key Responsibilities:

• Contribute to the development and execution of global regulatory strategy for the US, EU, UK, and Japan.
• Manage interactions with the UK MHRA for CTA submissions using IRAS Combined Review system (sub-IRAS).
• Lead the preparation, authoring, and review of major regulatory submissions, including NDA, MAA, and JNDA components.
• Support and, when appropriate, lead interactions with the FDA, EMA, and PMDA.
• Partner with external regulatory consultants, publishers, and regional agents to ensure high-quality deliverables aligned with the global regulatory strategy.

Position Requirements:

• Minimum of BS in Biology, Chemistry, or related discipline.
• 10+ years of regulatory affairs experience in the biopharmaceutical industry.
• Proven success leading global submissions (NDA + MAA).
• Deep expertise with MAA (Marketing Authorization Application) submissions.
• Experience managing day-to-day EU rare disease regulatory activities.
• Background as a GRL (Global Regulatory Lead) in Europe, or a US based regulatory leader with extensive firsthand UK/EU filing experience.

TSP is an affirmative action/equal opportunity employer (Minorities/Females/Veterans/Disabled)