Director, Regulatory Affairs

EPM Scientific; New Jersey; On-site; USD 150,000 - 190,000; Full time

Job summary

EPM Scientific is seeking a Director, Regulatory Affairs to lead regulatory strategy and execution across the development pipeline. In this hands-on role, you will partner with Clinical Development, R&D, and Quality to advance programs through FDA and global milestones.

You will drive regulatory filings, provide guidance to cross-functional teams, assess risks, and manage interactions with health authorities, shaping the regulatory strategy for multiple development programs in a growing

Qualifications

• 10+ years of Regulatory Affairs experience in biotech or pharma.
• Proven track record in regulatory strategy and submissions.
• Knowledge of global regulatory frameworks (FDA/EMA).

Responsibilities

• Lead regulatory strategy and execution for assigned development programs.
• Support preparation and submission of regulatory filings, including INDs and marketing applications.
• Provide regulatory guidance to cross-functional teams throughout the development lifecycle.
• Assess regulatory risks and develop mitigation strategies.
• Support regulatory interactions and communications with health authorities.
• Ensure compliance with FDA and international regulatory requirements.

Skills

Regulatory strategy

Regulatory submissions

Cross-functional

Job description

A clinical-stage biotech is seeking a Director, Regulatory Affairs to support regulatory strategy and execution across its development pipeline. This is a hands-on, high-impact individual contributor role that will partner closely with Clinical Development, R&D, and Quality teams to advance programs through key regulatory milestones while ensuring alignment with FDA and global regulatory requirements. This is an exciting opportunity to join a growing, innovative biotech and play a key role in shaping the regulatory strategy for multiple development programs.

Key Responsibilities:

• Lead regulatory strategy and execution for assigned development programs
• Support the preparation and submission of regulatory filings, including INDs and marketing applications
• Provide regulatory guidance to cross-functional teams throughout the development lifecycle
• Assess regulatory risks and develop mitigation strategies
• Support regulatory interactions and communications with health authorities
• Ensure compliance with FDA and international regulatory requirements

Qualifications:

• 10+ years of Regulatory Affairs experience within biotech or pharma
• Proven track record contributing to regulatory strategy and submissions
• Working knowledge of global regulatory frameworks, including FDA, EMA, and other international agencies
• Strong communication, collaboration, and stakeholder management skills