Eikontherapeutics

Director, Regulatory Affairs

Jersey City, NJ · Director

Sponsorship not specified$213k-$257kDetected 2 days ago

GCPComplianceFDA RegulatoryLeadershipCommunicationCollaborationProblem SolvingRegulatory Affairs

About the role

Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for life-threatening diseases.
In this role, you will play a key role in both shaping regulatory strategy and driving hands-on execution across assigned programs.
About You You are a seasoned regulatory affairs professional with strong hands-on experience through clinical regulatory affairs content and strategy, and navigating FDA and international regulatory frameworks.

Responsibilities

Program-Focused Regulatory Leadership: Provide strategic and hands-on regulatory support across assigned clinical development programs, partnering closely with cross-functional teams to guide development and regulatory decision-making.
Regulatory Compliance: Maintain current knowledge of evolving regulations, guidance, and industry best practices to ensure ongoing compliance across programs.
Submission Management: Lead and/or support the preparation, review, and submission of regulatory documents, including INDs, NDAs, and MAAs, as applicable.
Cross-Functional Collaboration: Work closely with Clinical Development, R&D, Quality, and other stakeholders to integrate regulatory considerations throughout the development lifecycle and drive alignment.
Quality Support: Support regulatory aspects of quality systems, including compliance with GCP and GLP requirements.
Provide strategic and hands-on regulatory support across assigned clinical development programs, partnering closely with cross-functional teams to guide development and regulatory decision-making.
Lead and/or support the preparation, review, and submission of regulatory documents, including INDs, NDAs, and MAAs, as applicable.
Work closely with Clinical Development, R&D, Quality, and other stakeholders to integrate regulatory considerations throughout the development lifecycle and drive alignment.
Support regulatory aspects of quality systems, including compliance with GCP and GLP requirements.

Requirements

Post-graduate degree with 10+ years of relevant regulatory affairs experience, or a Bachelor's degree with 12+ years of experience.
Strong working knowledge of FDA and international regulatory requirements (including regions such as EU, Japan, China) and guidelines.
Excellent written and verbal communication skills, with the ability to influence cross-functional stakeholders.
Ability to thrive as an individual contributor in a dynamic, high-growth environment.
You are a seasoned regulatory affairs professional with strong hands-on experience through clinical regulatory affairs content and strategy, and navigating FDA and international regulatory frameworks.
You bring excellent communication, organizational, and problem-solving skills, and thrive in highly collaborative, fast-paced environments where you are expected to both think strategically and execute with rigor.
Demonstrated experience contributing to clinical regulatory content and strategy and managing regulatory submissions.
Strong analytical skills, attention to detail, and sound judgment.
At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including:
401k plan with company matching
Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%)
Mental health and wellness benefits
Weeklong summer and winter holiday shutdowns
Generous paid time off and holiday policies
Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies

Nice to have

Prior experience supporting oncology development programs is strongly preferred.

Compensation

At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including:

Benefits

Enhanced parental leave benefit

Company info

Contribute to the development and execution of regulatory strategies supporting product development, approval, and commercialization in alignment with company objectives.

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