Director, Regulatory Affairs

TSP, a Syneos Health company; United States; On-site; USD 180,000 - 240,000; Full time

Job summary

TSP, a Syneos Health company, seeks a Director/Senior Director of Regulatory Affairs to lead global regulatory strategy for US, EU, UK, and Japan, shaping submissions and agency interactions in a small biotech setting.

The role oversees NDA/MAA programs, partners with the VP and external consultants, and requires 10+ years in regulatory affairs with proven NDA/MAA leadership.

Qualifications

• BS in biology, chemistry, or a related field is required.
• 10+ years in regulatory affairs within biopharma.
• Proven success leading NDA and MAA submissions.
• Experience with EU rare disease regulatory activities and UK/EU filings.

Responsibilities

• Shape global regulatory strategy for US, EU, UK, and Japan.
• Lead major submissions: NDA, MAA, JNDA components.
• Engage with FDA, EMA, PMDA and other regulators.
• Collaborate with external consultants and regional agents.

Skills

Regulatory strategy

Global submissions

Agency engagement

Cross-functional leadership

UK/EU filing

Education

BS in Biology or Chemistry

Tools

IRAS Submissions System

Job 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.

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)