Manager, Regulatory Submission Publisher

Eikon Therapeutics, Inc.; Jersey City (NJ); On-site; USD 113,000 - 124,000; Full time

Job summary

An innovative biopharmaceutical company is seeking a meticulous Manager of Regulatory Submission Publishing to lead the regulatory submissions process. This role involves managing the end-to-end publishing of INDs, NDAs, and BLAs while ensuring compliance with global health authority requirements. The ideal candidate will thrive in a collaborative environment, utilizing their expertise in regulatory processes and electronic publishing tools to support a growing team. Join a forward-thinking organization where your contributions will drive significant advancements in the treatment of life-threatening diseases.

Benefits

401k plan with company matching

95% medical premiums covered

100% dental and vision premiums covered

Mental health and wellness benefits

Generous paid time off

Enhanced parental leave benefit

Daily subsidized lunch program

Weeklong holiday shutdowns

Qualifications

• 5+ years of experience in regulatory submissions publishing.
• Strong understanding of global regulatory requirements (FDA, EMA, ICH).
• Proficiency in electronic submissions tools.

Responsibilities

• Manage the publishing of regulatory submissions in electronic and paper formats.
• Collaborate with cross-functional teams to compile submission documents.
• Ensure compliance with document management systems and version control.

Skills

Regulatory processes

Project management

Analytical skills

Interpersonal skills

Communication skills

Education

Bachelor's degree in Life Sciences

Master's degree in a relevant field

PhD in a related discipline

Tools

eCTD software

Adobe Acrobat

Document management systems

Job description

Manager, Regulatory Submission Publisher

Join to apply for the Manager, Regulatory Submission Publisher role at Eikon Therapeutics

Manager, Regulatory Submission Publisher

Join to apply for the Manager, Regulatory Submission Publisher role at Eikon Therapeutics

Get AI-powered advice on this job and more exclusive features.

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 Publisher. 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 end to end publishing (preparation through delivery) of regulatory submissions (e.g., INDs, NDAs, BLAs) in electronic and paper formats according to global health authority requirements.
• Serves as the point of contact for document formatting, PDF specifications and eCTD authoring templates. Manages document workflows in Veeva Submissions as needed and gathers submission documents from functional areas.
• 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:

• Typically requires a minimum of 5 years of related experience with a Bachelor’s degree; or 3 years and a Master’s degree; or a PhD without experience; or equivalent work experience in a relevant field such as Life Sciences, Biostatistics, Computer Science, or a related discipline.
• Prior experience 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.

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.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Legal

Referrals increase your chances of interviewing at Eikon Therapeutics by 2x

Sign in to set job alerts for “Regulatory Manager” roles.

New York, NY $115,200.00-$163,000.00 1 week ago

New York City Metropolitan Area 5 days ago

Associate Regulatory Affairs Manager – Beauty & Wellbeing and Personal Care

New York, NY $90,000.00-$140,000.00 5 months ago

New York City Metropolitan Area 5 days ago

New York City Metropolitan Area 1 week ago

New York City Metropolitan Area $160,000.00-$200,000.00 5 days ago

Quality Assurance & Regulatory Compliance Director

New York City Metropolitan Area $140,000.00-$180,000.00 3 weeks ago

Director (C15) Global Regulatory Remediation Execution Lead

New York, NY $170,000.00-$300,000.00 1 week ago

New York City Metropolitan Area 5 days ago

Food Safety & Regulatory Compliance Specialist

New York City Metropolitan Area $130,000.00-$180,000.00 3 weeks ago

Compliance Manager, Regulatory Change Management

New York, NY $105,600.00-$198,000.00 6 days ago

New York, NY $100,000.00-$225,000.00 4 days ago

Compliance and Quality Improvement Manager

New York, NY $120,000.00-$135,000.00 1 month ago

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.