Regulatory Submissions Manager - eCTD Lead

SK Life Science, Inc.; Paramus (NJ); On-site; USD 115,000 - 140,000; Full time

Benefits offered by this job

401(k) plan with company match

Medical, dental, and vision coverage

Job summary

SK Life Science, Inc. in New Jersey seeks a Regulatory Operations Manager to drive regulatory submissions (IND/NDA) across development programs. You will coordinate cross-functional teams and ensure alignment with eCTD standards and health authority guidelines.

The role emphasizes planning, publishing, and maintaining submission content and timeliness, with opportunities to shape SOPs and digital archiving practices. Strong English language skills and detail-oriented execution are essential.

Qualifications

• Bachelor’s degree required.
• 4–6 years of eCTD publishing experience in pharmaceutical industry.
• Knowledge of health authority procedures/guidance regarding electronic submissions.
• Knowledge of IND, NDA, MAA, CTD requirements and guidelines.
• Technical knowledge of electronic publishing systems and software such as InSight Publisher, ViewPoint, eCTD Reviewer, Documentum, or Veeva.

Responsibilities

• Manage a wide variety of submissions (INDs, NDAs, CSRs, promotional materials, DSURs, responses).
• Plan and oversee submission content plans and resource planning for submissions.
• Assist in formatting and publishing documents to meet eCTD standards.
• Represent RegOps in cross-functional teams and guide speed-to-filing strategies.
• Support regulatory maintenance activities for development and late-stage products.
• Coordinate with Clinical/Nonclinical/CMC teams to collect documentation and manage timelines.
• Develop and improve submission standards and templates.
• Prepare and format high-quality documents for internal stakeholders.
• Lead or assist in writing departmental SOPs.
• Assist in digital archiving of correspondence with health authorities.

Skills

Fluency in English

Time management

Self-starter

Attention to detail

Explain technical requirements

Education

BA/BS degree or equivalent

Tools

InSight Publisher

ViewPoint

eCTD Reviewer

Documentum

Veeva

Job description

SK Life Science, Inc. in New Jersey seeks a Regulatory Operations Manager to drive regulatory submissions (IND/NDA) across development programs. You will coordinate cross-functional teams and ensure alignment with eCTD standards and health authority guidelines.

The role emphasizes planning, publishing, and maintaining submission content and timeliness, with opportunities to shape SOPs and digital archiving practices. Strong English language skills and detail-oriented execution are essential.