Eikon Therapeutics · 5 days ago
Senior Manager Regulatory Affairs
Jersey City, NJ
Full-time
Onsite
Senior Level
$157K/yr - $171K/yr
6+ years expEikon 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. They are seeking a Senior Manager, Regulatory Affairs, to ensure compliance with regulations and guide product development strategies while collaborating with cross-functional teams.
BiotechnologyHealth CareLife ScienceMedical
Responsibilities
Regulatory Strategy: execute regulatory strategies to support product development, approval, and commercialization, ensuring alignment with the company's goals and objectives
Regulatory Compliance: Stay current with all relevant regulations, guidelines, and industry best practices. Ensure that the company's activities and products adhere to applicable regulatory requirements
Submission Management: Prepare, review, and submit regulatory documents, including but not limited to Investigational New Drug (IND) applications, New Drug Applications (NDAs), and Marketing Authorization Applications (MAAs)
Cross-Functional Collaboration: Collaborate closely with R&D, Quality Assurance, Clinical Development, and other teams to provide regulatory guidance and ensure that regulatory considerations are integrated into product development
Quality Assurance: Oversee regulatory aspects of quality systems, including compliance with Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Good Laboratory Practices (GLP)
Risk Assessment: Identify and evaluate regulatory risks associated with projects and provide solutions to mitigate those risks
Qualification
Required
Post Graduate degree with 6+ years of experience or a Bachelor's degree with 8+ years of experience in a relevant scientific discipline
Strong knowledge of FDA and international regulatory requirements and guidelines
Excellent communication, negotiation, and project management skills
Ability to work effectively in a cross-functional team environment
Attention to detail, strong analytical skills, and problem-solving abilities
Adaptable and able to thrive 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 (12)
2024 (17)
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