Sr. Director, Regulatory Affairs

Finance & Legalposted 3w ago

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.

Position

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.

About You

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.

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.

Qualifications

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

The expected salary range for this role is $235,000 to $288,750 depending on skills, competency, and the market demand for your expertise.

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.