Senior Director, Regulatory Affairs at Eikon Therapeutics

Jersey City, New Jersey, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Biopharmaceutical, BiotechnologyIndustries

Requirements

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
Minimum of 3 days a week onsite presence in Jersey City (NJ) office (or more as business needs require)

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

Skills

Key technologies and capabilities for this role

FDA regulationsInternational regulatory requirementsRegulatory strategyRegulatory complianceIND submissionsNDA submissionsProject managementCross-functional collaborationNegotiationAnalytical skills

Questions & Answers

Common questions about this position

What is the work arrangement or location requirement for this role?

The role requires a minimum of 3 days a week of onsite presence (or more as business needs require) in the Jersey City (NJ) office to ensure effective management, operational excellence, and collaboration.

What are the key skills required for the Senior Director, Regulatory Affairs position?

The role requires in-depth knowledge of FDA and international regulatory requirements, exceptional communication, negotiation, and project management skills, plus strong analytical skills, attention to detail, problem-solving, and adaptability.

What does the company culture emphasize for this role?

The company emphasizes a collaborative, cross-functional team environment, with a focus on thriving in teamwork, regulatory integrity, transparency, and supporting team growth.

What makes a strong candidate for this position?

A strong candidate is a seasoned regulatory professional with proven experience developing and executing regulatory strategies, managing submissions like INDs and NDAs, ensuring compliance, and fostering cross-functional collaboration while liaising with agencies.

What is the salary or compensation for this role?

This information is not specified in the job description.

Eikon Therapeutics

Biotech startup developing innovative medicines

About Eikon Therapeutics

Eikon Therapeutics focuses on discovering and developing new medicines in the pharmaceutical industry. The company employs advanced technologies to study biological systems, aiming to identify new drug targets by examining the dynamic aspects of biology rather than just static chemical processes. Their team consists of diverse professionals, including data scientists, chemists, and engineers, which allows them to combine science and engineering to create new therapies that aim to improve and extend life. A key feature of Eikon's approach is their proprietary single-molecule tracking (SMT) platform, which enables rapid visualization of protein movements in living cells. This technology, along with artificial intelligence and automation, allows for precise inventorying of molecular interactions. Eikon Therapeutics targets patients with serious diseases who need effective treatments, generating revenue through the development and commercialization of their therapies.

Hayward, CaliforniaHeadquarters

2019Year Founded

$750.8MTotal Funding

SERIES_CCompany Stage

AI & Machine Learning, BiotechnologyIndustries

201-500Employees

Benefits

401(k) Company Match

Medical (premiums covered by Eikon at 95%)

Dental Insurance

Vision Insurance

Mental Health Support

Unlimited Paid Time Off

Paid Holidays

Life Insurance

Enhanced Parental Leave

Daily subsidized lunch program

Risks

Competition from biotech unicorns like Abogen Biosciences is increasing.

Integrating new clinical-stage assets may delay drug development timelines.

Reliance on SMT technology risks obsolescence from emerging molecular biology technologies.

Differentiation

Eikon uses proprietary single-molecule tracking for real-time protein movement analysis.

The company integrates AI and automation for large-scale molecular interaction studies.

Eikon's diverse team combines expertise in science, engineering, and technology.

Upsides

Growing interest in SMT technology boosts Eikon's drug discovery potential.

Partnerships with AI firms enhance Eikon's drug candidate identification.

Rising demand for precision medicine aligns with Eikon's focus on dynamic biology.

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