Associate Director, Regulatory Affairs at Eikon Therapeutics

Jersey City, New Jersey, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biopharmaceutical, BiotechnologyIndustries

Requirements

Seasoned regulatory professional with in-depth knowledge of ex-US regulatory requirements and guidelines (e.g., EU-CTR Regulation EU No 536/2014, ICH, country-specific regulations)
Exceptional project management, coordinating, and communication skills
Proven ability to thrive in a fluid, fast-paced, collaborative, cross-functional team environment
Strong analytical skills, attention to detail, effective problem-solving abilities, efficient execution, and adaptability
Minimum of 3 days a week onsite presence in the Jersey City, New Jersey office (or more as business needs require)

Responsibilities

Develop and execute comprehensive regulatory CTA submission strategies supporting clinical trial initiations ex-US, aligned with company strategic objectives
Provide advisory to and work with cross-functional teams on developing responses to health authority questions
Advise and stay abreast of evolving ex-US regulations, guidelines, and industry best practices
Ensure company activities and products adhere to all applicable regulatory requirements
Maintain detailed knowledge of regulations such as EU-CTR, ICH, and country-specific regulations
Develop and coordinate preparation, review, and submission of submission packages and regulatory documents for countries in Europe (EU countries, UK, Norway, Switzerland, Iceland), Latin America, Asia Pacific (Australia, New Zealand, China, South Korea), and rest of the world (ROW)
Develop ex-US dossier content plans in coordination with cross-functional teams
Maintain international CTA lifecycles
Collaborate closely with Study Start-Up (SSU), Clinical Operations Study Management, Clinical Supply Chain, CMC, and other teams to provide regulatory support

Skills

Regulatory Affairs

CTAs

ex-US Regulations

Project Management

Regulatory Compliance

Cross-Functional Collaboration

Analytical Skills

Problem-Solving

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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