Eikon Therapeutics · 5 hours ago
Senior Director, Regulatory Affairs
Jersey City, NJ
Full-time
Onsite
Director/Executive
$239K/yr - $261K/yr
12+ years expEikon Therapeutics is a new biopharmaceutical company focused on innovative technologies to discover treatments for life-threatening diseases. They are seeking a Senior Director of Regulatory Affairs to lead regulatory strategy and compliance efforts, ensuring alignment with regulations and guiding product development. The role requires collaboration with cross-functional teams and a commitment to regulatory integrity.
BiotechnologyHealth CareLife ScienceMedical
Responsibilities
Develop and execute comprehensive regulatory strategies that support product development, approval, and commercialization while aligning with the company's strategic objectives
Stay abreast of evolving regulations, guidelines, and industry best practices. Ensure that the company's activities and products adhere to all applicable regulatory requirements
Oversee the preparation, review, and submission of regulatory documents, including but not limited to Investigational New Drug (IND) applications, New Drug Applications (NDAs), and Marketing Authorization Applications (MAAs)
Collaborate closely with R&D, Quality Assurance, Clinical Development, and other teams to provide regulatory guidance and ensure the seamless integration of regulatory considerations into the product development process
Supervise regulatory aspects of quality systems, including compliance with Good Clinical Practices (GCP), and Good Laboratory Practices
Identify and assess regulatory risks associated with projects and proactively propose solutions to mitigate these risks
Qualification
Required
Post Graduate degree with 12+ years of experience or a Bachelor's degree with 15+ years of relevant experience
In-depth knowledge of FDA and international regulatory requirements and guidelines
Exceptional communication, negotiation, and project management skills
Proven ability to thrive in a collaborative, cross-functional team environment
Strong analytical skills, attention to detail, and effective problem-solving abilities
Adaptability and the ability to excel in a fast-paced, high-growth environment
Benefits
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
Enhanced parental leave benefit
Daily subsidized lunch program when on-site
Company
Eikon Therapeutics
Eikon Therapeutics is a biopharmaceutical company that develops live-cell resolution microscopy and engineering for drug discovery.
201-500 employees
H1B Sponsorship
Eikon Therapeutics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (10)
2024 (19)
2023 (7)
2022 (3)
2021 (1)
Funding
Current Stage
Late StageTotal Funding
$1.12BKey Investors
The Column Group
2025-02-26Series D· $350.7M
2023-06-01Series C· $106M
2022-01-06Series B· $518M
Leadership Team
Roger Perlmutter
Chairman, President, and CEO
Michael Klobuchar
Chief Operating Officer
Recent News
General Catalyst
2025-12-26
2025-12-02
Company data provided by crunchbase