Eblex Group
Job Title: Regulatory Affairs Consultant
Location: East Coast USA
About the Role
Eblex Group
are supporting a small Biotech on the East Coast of the US with their search for a
Regulatory Affairs Consultant
with a strong background in
clinical regulatory strategy, CTA submissions, within oncology development. This role will focus on preparing, coordinating, and managing global clinical trial applications (CTAs) and related regulatory submissions to support an expanding oncology pipeline. Key Responsibilities of the Regulatory Affairs Consultant
Lead the preparation, compilation, and submission of Clinical Trial Applications (CTAs), amendments, and related filings in accordance with FDA and global regulatory requirements. Partner with cross-functional teams (Clinical Operations, Medical Writing, CMC, and QA) to ensure timely and compliant regulatory submissions. Support regulatory strategy development for oncology programs, including first-in-human and early-phase trials. Prepare high-quality regulatory documentation including Investigator’s Brochures (IB), IMPDs, and clinical sections of INDs/CTAs. Manage interactions with regulatory authorities (e.g. FDA, EMA) and respond to Health Authority questions. Track regulatory milestones and maintain submission documentation within regulatory systems and archives. Provide regulatory input during protocol development, feasibility assessments, and clinical project planning. Support the development of regulatory proposals, project plans, and timelines for new oncology studies and collaborations. Ensure all submissions comply with ICH, GCP, and regional regulatory requirements. Qualifications
Bachelor’s or advanced degree in Life Sciences, Pharmacy, or related field. 5 - 8+ years of experience in Regulatory Affairs with a focus on clinical development and CTA submissions. Proven experience managing oncology clinical trial submissions (EU CTA / US IND preferred). Strong understanding of ICH, GCP, and global regulatory frameworks. Demonstrated experience in authoring and reviewing clinical regulatory documents (IBs, IMPDs, CTAs). Excellent communication, organization, and cross-functional collaboration skills. Ability to manage multiple priorities in a fast-paced biotech environment.
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Location: East Coast USA
About the Role
Eblex Group
are supporting a small Biotech on the East Coast of the US with their search for a
Regulatory Affairs Consultant
with a strong background in
clinical regulatory strategy, CTA submissions, within oncology development. This role will focus on preparing, coordinating, and managing global clinical trial applications (CTAs) and related regulatory submissions to support an expanding oncology pipeline. Key Responsibilities of the Regulatory Affairs Consultant
Lead the preparation, compilation, and submission of Clinical Trial Applications (CTAs), amendments, and related filings in accordance with FDA and global regulatory requirements. Partner with cross-functional teams (Clinical Operations, Medical Writing, CMC, and QA) to ensure timely and compliant regulatory submissions. Support regulatory strategy development for oncology programs, including first-in-human and early-phase trials. Prepare high-quality regulatory documentation including Investigator’s Brochures (IB), IMPDs, and clinical sections of INDs/CTAs. Manage interactions with regulatory authorities (e.g. FDA, EMA) and respond to Health Authority questions. Track regulatory milestones and maintain submission documentation within regulatory systems and archives. Provide regulatory input during protocol development, feasibility assessments, and clinical project planning. Support the development of regulatory proposals, project plans, and timelines for new oncology studies and collaborations. Ensure all submissions comply with ICH, GCP, and regional regulatory requirements. Qualifications
Bachelor’s or advanced degree in Life Sciences, Pharmacy, or related field. 5 - 8+ years of experience in Regulatory Affairs with a focus on clinical development and CTA submissions. Proven experience managing oncology clinical trial submissions (EU CTA / US IND preferred). Strong understanding of ICH, GCP, and global regulatory frameworks. Demonstrated experience in authoring and reviewing clinical regulatory documents (IBs, IMPDs, CTAs). Excellent communication, organization, and cross-functional collaboration skills. Ability to manage multiple priorities in a fast-paced biotech environment.
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