Job Functions1. Regulatory Submissions Publishing2. Project Management3. Compliance and Quality Control4. CrossFunctional Collaboration5. Vendor Management
Job Requirements1. 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.2. Prior experience leading regulatory submissions projects3. Strong understanding of global regulatory requirements and guidelines (FDA, EMA, ICH)4. Proficiency in electronic submissions tools and software (e.g., eCTD, document management systems)
Skills1. Electronic submissions tools and software (e.g., eCTD, document management systems)2. Strong analytical skills to identify issues and implement effective solutions3. Proficiency in project management with the ability to prioritize tasks and meet deadlines4. Excellent communication and interpersonal skills, with the ability to collaborate across functions and influence outcomes5. Detailoriented with a focus on quality and compliance
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.
Life at Eikon Therapeutics
Thrive Here & What We Value1. Passion for innovation and improving patient outcomes. | 2. Daily subsidized lunch program when onsite. | 3. Generous paid time off and holiday policies. | 4. Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employeepaid life/AD&D policies | 5. Enhanced parental leave benefit. | 6. Weeklong summer and winter holiday shutdowns. | 7. Mental health and wellness benefits.</s> | Equal Opportunity Employer | Generous Benefit Programs | Daily Subsidized Lunch Program</s> | Eikon Therapeutics is committed to creating a positive and inclusive workplace culture that values collaboration, innovation, and creativity. | The company offers generous benefits 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, 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. | Daily subsidized lunch program when on-site | Enhanced parental leave benefit</s> | 1. Innovative and forwardthinking approach to drug discovery | 2. Emphasis on collaboration and teamwork | 3. Focus on creating novel treatments for lifethreatening diseases | 4. Commitment to equal opportunity employment | 5. No thirdparty agencies or firms currently being considered</s> | 1. Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for lifethreatening diseases. | 2. 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, molecularresolution measurements of protein movement in living cells, thereby unlocking otherwise intractable classes of proteins as drug targets. | 3. 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 employeepaid life/AD&D policies, Enhanced parental leave benefit, Daily subsidized lunch program when on-site.</s> | 2. 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, molecularresolution measurements of protein movement in living cells, thereby unlocking otherwise intractable classes of proteins as drug targets. | Eikon Therapeutics is committed to discovering novel treatments for life-threatening diseases using groundbreaking innovations from its founders. | The company's discovery platform is built on revolutionary technology at the intersection of Chemistry, Engineering, Computation, and Biology. | Eikon values collaboration, agility, and operational excellence in building and leading in-house clinical operations study management teams.</s> | Mental health and wellness benefits</s> | 1. Eikon Therapeutics is an equal opportunity employer and will consider all qualified applicants for employment. | 2. Employee compensation includes bonus and equity compensation, in addition to several generous benefit programs. | 3. Daily subsidized lunch program when onsite. | 4. Weeklong summer and winter holiday shutdowns. | 5. Generous paid time off and holiday policies. | 6. Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employeepaid life/AD&D policies | 7. Enhanced parental leave benefit.</s> | Eikon Therapeutics is committed to creating an inclusive culture that values diverse perspectives, experiences, and backgrounds. | The company offers generous benefits programs, including medical, dental, and vision insurance, mental health and wellness benefits, paid time off, holiday policies, life/AD&D Insurance, parental leave benefit, and daily subsidized lunch program when on-site.</s> | 3. Focus on making a positive impact on patients' lives through novel treatments for lifethreatening diseases | 4. Supportive and inclusive work environment | 5. Opportunities for professional growth and development</s> | 1. Eikon Therapeutics is committed to creating a diverse and inclusive workplace culture that values collaboration, innovation, and excellence. | 2. The company offers generous benefits 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, paid time off and holiday policies, life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employeepaid life/AD&D policies. | 3. Eikon is proud to be an equal opportunity employer and will consider all qualified applicants for employment.</s> | 1. Employee compensation includes bonus and equity compensation, in addition to several generous benefit programs. | 2. Generous paid time off and holiday policies | 3. Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employeepaid life/AD&D policies | 4. Enhanced parental leave benefit | 5. Daily subsidized lunch program when onsite</s> | 3. Focus on improving patient outcomes through novel treatments | 4. Commitment to scientific excellence and integrity | 5. Support for professional development and growth</s> | 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%) | Daily subsidized lunch program when on-site</s> | 1. Dedication to promoting a culture of safety, sustainability, and compliance in a dynamic biotech environment | 2. Generous benefit programs, including 401k plan with company matching, medical, dental, and vision insurance, mental health and wellness benefits, weeklong summer and winter holiday shutdowns, paid time off and holiday policies, life/AD&D Insurance (premiums covered by Eikon at 100%), enhanced parental leave benefit, daily subsidized lunch program when onsite.</s> | 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. | At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including: 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.</s> | 2. Collaborative and supportive environment | 3. Emphasis on teamwork and communication | 4. Focus on making a positive impact in the world through novel treatments for lifethreatening diseases | 5. Commitment to equal opportunity employment</s> | 1. Equal Opportunity Employer | 5. Enhanced Parental Leave Benefit</s>
