Senior Regulatory Submissions Lead

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

Benefits offered by this job

401(k) plan with company match

Medical coverage

Dental coverage

Vision coverage

Job summary

SK Life Science seeks a Regulatory Operations Manager to lead planning and delivery of regulatory submissions (IND, NDA) for new products in Paramus, NJ. You will ensure eCTD standards, coordinate cross-functional content plans, and support regulatory maintenance throughout development stages.

The role requires 4–6 years in eCTD publishing, familiarity with health authority procedures, and strong document formatting/editing skills in Word and Acrobat. Fluency in English is essential.

Qualifications

• BA/BS degree or equivalent.
• 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.
• Experience with electronic publishing systems and software (e.g., InSight Publisher, ViewPoint, eCTD Reviewer, Documentum). Veeva is a plus.

Responsibilities

• Manages a wide variety of submissions, such as promotional materials (2253), CSRs, investigators' brochures, DSURs, regulatory responses, original INDs and amendments.
• Plans and oversees assigned submissions with content plans and resource planning.
• Assist in formatting and publishing documents to meet eCTD standards.
• May represent RegOps in cross-functional teams and guide strategies for speed-to-filing or health authority requirements.
• Supports regulatory maintenance activities for early development and late-stage products.
• Coordinate submission timelines with Clinical, Nonclinical, CMC teams.
• Develop/update submission standards and templates.
• Organize preparation/formatting of high-quality documents for internal stakeholders.
• Lead/assist in drafting departmental SOPs.
• Assist in digital archiving of correspondence with health authorities.

Skills

ectd publishing

health authority guidelines

eCTD standards

Microsoft Word

Adobe Acrobat

time management

English fluency

Education

Bachelor's degree

Tools

InSight Publisher

ViewPoint

eCTD Reviewer

Documentum

Veeva

Job description

SK Life Science seeks a Regulatory Operations Manager to lead planning and delivery of regulatory submissions (IND, NDA) for new products in Paramus, NJ. You will ensure eCTD standards, coordinate cross-functional content plans, and support regulatory maintenance throughout development stages.

The role requires 4–6 years in eCTD publishing, familiarity with health authority procedures, and strong document formatting/editing skills in Word and Acrobat. Fluency in English is essential.