Director, Regulatory CMC

Jersey City, NJ

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.

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) offices to ensure effective management, operational excellence and high-performance delivery of clinical studies and to support the expected significant team growth & collaboration.

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.
  • Manage a team of regulatory CMC professionals and provide guidance and support for regulatory affairs activities.
  • 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 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.
  • Experience managing and leading a team of regulatory affairs professionals.
  • 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.

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.

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