New · posted Oct 15
Eikon Therapeutics · Biotechnology
Sr. Director, Regulatory Affairs
- Jersey City, NJ
- Hybrid
- Full-time
- Director
Open until filled
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. Eikon’s discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), culminating in the creation of microscopes which enable real time, molecular-resolution measurements of protein movement in living cells, thereby unlocking otherwise intractable classes of proteins as drug targets.
We are seeking an experienced Senior Director, Regulatory Affairs, to lead our regulatory strategy and compliance efforts. In this critical role, you will be responsible for ensuring that our biotechnological innovations align with all relevant regulations and standards. You will collaborate with cross-functional teams to guide product development and market entry strategies while maintaining a steadfast commitment to regulatory integrity and transparency.
This role will require a minimum of 3 days a week of onsite presence (or more as business needs require) in our Jersey City (NJ) office to ensure effective management, operational excellence and high-performance delivery of clinical studies and to support the expected significant team growth & collaboration.
What you need
The ideal candidate for this role is a seasoned regulatory professional who possesses in-depth knowledge of FDA and international regulatory requirements and guidelines, coupled with exceptional communication, negotiation, and project management skills. Their proven ability to thrive in a collaborative, cross-functional team environment, along with strong analytical skills, attention to detail, effective problem-solving abilities, and adaptability, makes them well-suited for the position. In this role, they will excel in developing and executing regulatory strategies, ensuring compliance, managing submissions, fostering cross-functional collaboration, liaising with regulatory agencies, supervising quality assurance, and addressing regulatory risks associated with projects.
- 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.
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
- Enhanced parental leave benefit
- Daily subsidized lunch program when on-site
What you'll do
- Regulatory Strategy: Develop and execute comprehensive regulatory strategies that support product development, approval, and commercialization while aligning with the company's strategic objectives.
- Regulatory Compliance: Stay abreast of evolving regulations, guidelines, and industry best practices. Ensure that the company's activities and products adhere to all applicable regulatory requirements.
- Submission Management: 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).
- Cross-Functional Collaboration: 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.
- Quality Assurance: Supervise regulatory aspects of quality systems, including compliance with Good Clinical Practices (GCP), and Good Laboratory Practices.
- Risk Assessment: Identify and assess regulatory risks associated with projects and proactively propose solutions to mitigate these risks.
Pay and benefits
$235,000 – $288,750 a year
Employer providedThe expected salary range for this role is $235,000 to $288,750 depending on skills, competency, and the market demand for your expertise.
401k with company matching
Medical, dental and vision insurance
Mental health and wellness benefits
Generous paid time off and holidays
Enhanced parental leave
Bonus and equity compensation
Where you'll work
Jersey City, NJHybridOpen in Maps (opens in a new tab)
More jobs in Jersey City, NJEqual opportunity, accessibility and legal noticesEikon Therapeutics's statements, word for word
Eikon is proud to be an equal opportunity employer and will consider all qualified applicants for employment.
We are currently not accepting any new third-party agencies or firms at this time. Please do not forward unsolicited agency resumes to our website, employees or Human Resources. Eikon Therapeutics will not pay fees to any third-party agency or firm associated with unsolicited resumes.
Job intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
This role's midpoint is 11% above the US median for Regulatory Affairs roles at this level.
This roleEmployer provided
Director roles in New Jersey12 roles publishing pay
Director roles in the US101 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $235,000 | — | $288,750 |
| New Jersey (middle half) | $242,875 | $263,000 | $264,000 |
| All US (middle half) | $209,500 | $235,000 | $264,000 |
This role: Eikon Therapeutics's own published range. Comparisons: the base pay employers published on open Regulatory Affairs roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory Affairs
The general path across 290 open Regulatory Affairs roles on Regulatory Jobs, with the titles they carry most. Not Eikon Therapeutics's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 25 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership6
- GMP and compliance4
- Regulatory submissions4
- Lab testing and methods3
- Quality systems and risk2
- Data and digital systems2
- Documentation and SOPs1
- Investigations and CAPA1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDA21 CFR Part 58 (GLP)(official source, opens in a new tab)Good laboratory practice for nonclinical laboratory studies
- ICHICH E6 good clinical practice(official source, opens in a new tab)The international standard for the conduct of clinical trials
- FDAFDA IND(official source, opens in a new tab)Investigational New Drug applications
- FDAFDA NDA(official source, opens in a new tab)New Drug Applications
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
Eikon Therapeutics on Regulatory Jobs
- 3
- Open roles
- 3
- Distinct roles
- 2
- Locations
By discipline
- Regulatory2 67%
- Compliance & Safety1 33%
By level
- Director2 67%
- Manager1 33%
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Sr. Director, Regulatory Affairs at Eikon Therapeutics
Open until filled. $235K–$289K a year, employer provided.