Senior Director Regulatory Strategy

EPM Scientific; Jersey City (NJ); Hybrid; USD 180,000 - 240,000; Full time

Job summary

EPM Scientific is seeking a Senior Director of Regulatory Affairs to build and lead our regulatory strategy as we enter a growth phase in the biotechnology space. This role partners with R&D, Clinical Development and Quality to guide product development and market entry from end to end.

You will own the regulatory roadmap, manage major submissions (IND, NDA, MAA), and ensure ongoing compliance with FDA and international requirements.

Qualifications

• Advanced degree with 12+ years in regulatory affairs
• Bachelor's degree with 15+ years in regulatory affairs
• Experience leading regulatory submissions and cross-functional teams
• Strong communication and negotiation skills
• Ability to operate in a fast-paced, high-growth environment

Responsibilities

• Build and lead regulatory strategy for product development, approval, and commercialization
• Oversee preparation and submission of regulatory filings (IND, NDA, MAA)
• Serve as strategic regulatory partner across R&D, Clinical Development and QA
• Monitor FDA and international requirements to ensure ongoing compliance (GCP/GLP)
• Identify regulatory risks early and drive mitigation strategies

Skills

Regulatory strategy

FDA/intl regulatory frameworks

Cross-functional leadership

Project management

Regulatory submissions

Education

Advanced degree in regulatory affairs

Bachelor's degree with 15+ years regulatory experience

Job description

Location: Northern NJ / Greater NYC Metro (Hybrid - minimum 3 days onsite) Job Type: Full-Time, Permanent Industry: Biotechnology / Pharmaceuticals

About the Opportunity

We are working with a clinical-stage biotechnology company developing novel treatments for life-threatening diseases, currently seeking a Senior Director of Regulatory Affairs to build and lead regulatory strategy as the organization enters a period of significant growth. This is a rare chance to shape a regulatory function from the ground up and play a foundational role as the team scales.

You'll partner closely with cross-functional leaders across R&D, Clinical Development, and Quality to guide product development and market entry, while owning the regulatory roadmap end to end.

Key Responsibilities

• Build and execute regulatory strategy supporting product development, approval, and commercialization
• Lead preparation and submission of key regulatory filings (IND, NDA, MAA)
• Act as the strategic regulatory partner across R&D, Clinical Development, and Quality Assurance
• Monitor evolving FDA and international regulatory requirements to ensure ongoing compliance (GCP/GLP)
• Identify regulatory risk early and drive proactive mitigation strategies

Qualifications

• Advanced degree with 12+ years of experience, or Bachelor's degree with 15+ years in regulatory affairs
• Strong working knowledge of FDA and international regulatory frameworks
• Track record leading regulatory submissions and cross-functional teams
• Excellent communication, negotiation, and project management skills
• Comfortable operating in a fast-paced, high-growth environment