EPM Scientific
Associate Director Regulatory Affairs
EPM Scientific, Jersey City, New Jersey, United States, 07390
EPM Scientific
Associate Director Regulatory Affairs Location: Jersey City, NJ
Base pay range $175,000.00/yr - $195,000.00/yr
Key Responsibilities
Design and implement regulatory strategies for clinical trial applications (CTAs) outside the U.S., ensuring alignment with organizational goals and timelines.
Lead the preparation, review, and coordination of regulatory submission packages across multiple regions (EU, UK, LATAM, APAC, etc.)
Develop dossier content plans in collaboration with internal stakeholders.
Oversee the lifecycle management of international CTAs.
Provide strategic input and support to cross-functional teams in preparing responses to health authority inquiries.
Monitor and interpret evolving global regulatory requirements, guidelines, and industry standards.
Ensure all clinical trial activities comply with applicable international regulations, including EU-CTR (Regulation EU No 536/2014), ICH guidelines, and country-specific legislation.
Serve as the primary contact for regulatory authorities regarding submissions and follow-ups.
Ensure regulatory compliance with quality systems, including GCP and GDPR.
Identify potential regulatory risks and recommend mitigation strategies proactively.
Qualifications
Bachelor's degree with 10+ years of relevant experience, or advanced degree with 8+ years in a scientific or regulatory discipline.
Hands on experience supporting multiple CTA filings.
Deep understanding of international regulatory frameworks and submission platforms (e.g., CTIS, IRIS).
Experience with documentation required by global health authorities, including clinical and GMP-related materials.
Strong communication, negotiation, and project management capabilities.
Proven success in cross-functional collaboration and regulatory strategy execution.
Comfortable working in a dynamic, fast-paced environment.
Proficiency in digital tools including Veeva Vault, Microsoft Office Suite, and other regulatory systems.
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Associate Director Regulatory Affairs Location: Jersey City, NJ
Base pay range $175,000.00/yr - $195,000.00/yr
Key Responsibilities
Design and implement regulatory strategies for clinical trial applications (CTAs) outside the U.S., ensuring alignment with organizational goals and timelines.
Lead the preparation, review, and coordination of regulatory submission packages across multiple regions (EU, UK, LATAM, APAC, etc.)
Develop dossier content plans in collaboration with internal stakeholders.
Oversee the lifecycle management of international CTAs.
Provide strategic input and support to cross-functional teams in preparing responses to health authority inquiries.
Monitor and interpret evolving global regulatory requirements, guidelines, and industry standards.
Ensure all clinical trial activities comply with applicable international regulations, including EU-CTR (Regulation EU No 536/2014), ICH guidelines, and country-specific legislation.
Serve as the primary contact for regulatory authorities regarding submissions and follow-ups.
Ensure regulatory compliance with quality systems, including GCP and GDPR.
Identify potential regulatory risks and recommend mitigation strategies proactively.
Qualifications
Bachelor's degree with 10+ years of relevant experience, or advanced degree with 8+ years in a scientific or regulatory discipline.
Hands on experience supporting multiple CTA filings.
Deep understanding of international regulatory frameworks and submission platforms (e.g., CTIS, IRIS).
Experience with documentation required by global health authorities, including clinical and GMP-related materials.
Strong communication, negotiation, and project management capabilities.
Proven success in cross-functional collaboration and regulatory strategy execution.
Comfortable working in a dynamic, fast-paced environment.
Proficiency in digital tools including Veeva Vault, Microsoft Office Suite, and other regulatory systems.
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