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Director, Regulatory CMC

$213,000- $232,750
Posted May 22
Full Time
Jersey City, New Jersey

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

The Director, Regulatory CMC will be responsible for overseeing the development and execution of regulatory strategies for Chemistry, Manufacturing, and Controls (CMC) aspects of our pharmaceutical products. The ideal candidate will have a deep understanding of regulatory requirements and guidelines related to CMC aspects of pharmaceutical products, as well as experience leading regulatory affairs activities for a biotech or pharmaceutical company.

About You

You’re a Regulatory CMC expert and leader who loves to solve difficult problems and are not discouraged by challenges. You’re a hands-on project manager who thrives in a fast-paced, dynamic environment. You’re well-organized, detail oriented, and take pride in your ability to rapidly analyze situations and judicious decisions. You’re collaborative by nature with uncompromising integrity. You’re conscientious and pay almost obsessive attention to detail, documentation and organization are second nature. You thrive on the excitement of being a foundational member of a rapidly growing high visibility team.

What You’ll Do

  • Develop and implement regulatory strategies for CMC aspects of our pharmaceutical products, including preparing and submitting regulatory submissions to regulatory agencies.
  • Interact with regulatory agencies to ensure compliance with regulatory guidelines and regulations related to CMC aspects of pharmaceutical products.
  • Collaborate with cross-functional teams to ensure regulatory compliance and timely product development.
  • Keep up to date with current regulatory requirements and guidelines related to CMC aspects of pharmaceutical products.
  • Provide strategic input on CMC aspects of product development and ensure that development plans meet regulatory requirements.
  • Manage and oversee CMC-related activities for regulatory inspections and audits.
  • Participate in the development and implementation of regulatory policies and procedures related to CMC aspects of pharmaceutical products.

Qualifications

  • Post Graduate degree with 10+ years of experience or a Bachelor's degree with 12+ years of experience in a relevant scientific discipline is required.
  • Experience in regulatory affairs, with a focus on CMC aspects of pharmaceutical products.
  • Strong understanding of regulatory guidelines and regulations related to CMC aspects of pharmaceutical products, including experience with regulatory submissions and interactions with regulatory agencies.
  • Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams.
  • Ability to work in a fast-paced, dynamic environment and manage multiple priorities simultaneously.
  • Strong attention to detail and ability to work independently.

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 $213,000 to $232,750 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.

In accordance with the Company’s duty to provide and maintain a safe workplace, the Company requires all employees to be Fully Vaccinated with one of the FDA approved COVID-19 vaccines, which includes those vaccines that have received the FDA’s emergency use authorization. You will be expected to be Fully Vaccinated as of your Start Date. If you believe that you are exempt from this requirement under an applicable law or regulations, including Americans with Disabilities Act and California’s Fair Employment and Housing Act, you will need to contact the Company’s Human Resources group. For purposes of this section, Fully Vaccinated means (i) the completion of the vaccination regimen as approved by the FDA (by way of example, 2 doses of the Pfizer or Moderna vaccine and 1 dose of the Johnson and Johnson vaccine), and (ii) timely receiving booster vaccination, as recommended by the Centers for Disease Control and Prevention.

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.