What are the responsibilities and job description for the Manager, Regulatory Submission Publisher position at Eikon Therapeutics?
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 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:
- 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 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.
Salary : $113,000 - $123,500
