Job Title: Regulatory Affairs
Location: New Jersey (Hybrid)
Position Type: Full-time
Salary: $80,000-$150,000 annual base, based on experience

Join a Global Regulatory Affairs Team – Drive Innovative Drug Approvals!

We are looking for a dedicated professional to support global regulatory activities and contribute to the successful registration of innovative drugs across the US, EU, and Japan. This role provides the opportunity to collaborate with an experienced Regulatory Affairs leader on Phase II/III IND and NDA submissions.

Key Responsibilities:

• Support global regulatory projects while ensuring compliance with relevant regulations and guidelines.
• Assist in the compilation and submission of regulatory documents, including INDs, CTAs/IMPDs, annual reports, progress reports, and briefing materials.
• Contribute to global marketing authorization strategies and regulatory submissions.
• Work closely with the global regulatory lead to establish submission timelines, project plans, content structures, and responsibility matrices.
• Maintain high-quality standards and consistency across all regulatory filings.
• Oversee regulatory document management systems and infrastructure.

Qualifications & Experience:

• Bachelor’s degree in a scientific or clinical field (advanced degree preferred).
• At least 5 years of experience in the pharmaceutical or biotechnology industry, with a minimum of 3 years in global regulatory affairs for innovative drug registration.
• Proficiency in managing INDs/CTAs, annual reports/DSURs, and submission amendments.
• Experience in preparing and reviewing eCTD-format regulatory submissions.
• Direct FDA interaction is a plus.
• Strong skills in submission writing and document review.
• Excellent organizational and time management abilities, with a proactive and detail-oriented mindset.
• Strong communication and collaboration skills to work effectively across functions.

If you're passionate about regulatory affairs and eager to make an impact in global drug development, we welcome you to join our team!