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Manager, Regulatory Submissions Publisher

Employer
Eikon Therapeutics
Location
Jersey City, NJ
Start date
May 27, 2024

View more

Discipline
Regulatory, Regulatory Affairs
Required Education
Bachelors Degree
Position Type
Consultant
Hotbed
Best Places to Work

Job Details

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 a highly organized and detail-oriented individual to join our team as a Manager, Submissions Publishing. In this role, you will be responsible for overseeing the regulatory submissions publishing process, ensuring compliance with industry standards and timelines. This role will require a minimum of 3 days a week of onsite presence (or more as business needs require) in our New Jersey 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:

You have a thorough understanding of regulatory processes and requirements for submissions. You have the ability to motivate and develop a team to achieve departmental objectives. You are familiar with electronic publishing tools and software used in regulatory submissions. You have strong analytical skills to identify issues and implement effective solutions. You are skilled in building effective relationships and working collaboratively with internal and external stakeholders.

Key Responsibilities:

  • Manage the preparation, publishing, and delivery of regulatory submissions (e.g., INDs, NDAs, BLAs) in electronic and paper formats according to global health authority requirements.
  • Lead a team of submissions specialists and coordinators, providing guidance and support to ensure accurate and timely submissions.
  • Collaborate with cross-functional teams, including Regulatory Affairs, Clinical Development, and Quality Assurance, to compile submission documents and resolve issues.
  • Maintain knowledge of regulatory guidelines and industry standards related to electronic submissions (eCTD) and publishing tools (e.g., eCTD software, Adobe Acrobat).
  • Ensure compliance with document management systems and version control procedures for regulatory submissions.
  • Coordinate with external vendors and consultants as needed for submissions-related activities.
  • Support regulatory inspections and audits by providing requested documentation and ensuring inspection readiness.
  • Stay abreast of emerging trends and best practices in regulatory submissions publishing and contribute to process improvement initiatives.

Qualifications and Experience:

  • Post Graduate degree with 3+ years of experience or a Bachelor's with 5+ years of experience in a relevant field such as Life Sciences, Biostatistics, Computer Science, or a related discipline.
  • Prior experience managing a team or leading regulatory submissions projects.
  • Strong understanding of global regulatory requirements and guidelines (FDA, EMA, ICH).
  • Proficiency in electronic submissions tools and software (e.g., eCTD, document management systems).
  • Excellent project management skills with the ability to prioritize tasks and meet deadlines.
  • Effective communication and interpersonal skills, with the ability to collaborate across functions and influence outcomes.
  • Detail-oriented with a focus on quality and compliance.

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 $113,000 to $123,500 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.

Company

Eikon is a pioneering drug discovery and development company that leverages superior engineering and high-performance computing to analyze single molecule protein behavior in living cells. We are engineering a battery of innovative tools and technologies for biological exploration in drug discovery and beyond.

Eikon thrives on the energy and creativity of interdisciplinary teams. We are physicists and chemists, biologists and engineers. We spend our days context-switching between multiple scientific languages. We work with lasers, super-resolution microscopes, and robot arms. We leverage machine learning, cell line engineering, and the collective intelligence of world-class scientists and technologists to observe therapeutically relevant biology in a way no one has before.

We’re endlessly curious, intellectually honest and we love what we do. We’re driven to learn the true mechanisms of biology and pharmacology at the molecular level, to make the biggest difference in as many lives as possible.

Company info
Website
Location
3929 Point Eden Way
Hayward
CA
94545
US

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