Manager, Regulatory Operations

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

The Regulatory Operations Manager will primarily be responsible for managing the planning and delivery of regulatory submissions (IND, NDA, Agency Responses, others) required to support the development and registration of new products. This includes a supporting role in adhering to and maintaining processes and requirements for the capability.

Responsibilities

• Manages a wide variety of submissions, such as promotional materials (2253), clinical study reports (CSRs), investigator’s brochures, DSURs, regulatory responses, original INDs and amendments.
• Plans and oversees assigned submissions with responsibilities including development and management of submission content plans and resource planning for assigned submissions.
• Assist in the formatting and "publishing" of documents to ensure they meet eCTD (Electronic Common Technical Document) standards.
• May represent RegOps in cross-functional teams, such as product, project and/or regulatory submissions teams; providing guidance for optimal strategies to achieve speed-to-filing or meet technical health authority requirements.
• Supports regulatory maintenance activities for early development and late-stage products.
• Help manage submission timelines by coordinating with cross-functional teams (Clinical, Nonclinical, CMC) to collect necessary documentation.
• Participates in development/improvement of submission standards, submission templates, and other submission related decisions.
• Organizes preparation/formatting of high-quality documents for internal stakeholders.
• Leads/Assists in the writing of departmental SOPs.
• Assist in the digital archiving of correspondence with health authorities and final submitted sequences.

Qualifications

Education: BA/BS degree or equivalent

Experience

• Minimum of 4-6 years of eCTD publishing experience in pharmaceutical industry.
• Knowledge of health authority procedures/guidance regarding electronic submissions.
• Knowledge of industry trends regarding electronic submissions.
• Knowledge of IND, NDA, MAA, CTD requirements and guidelines.
• Technical knowledge of electronic publishing systems and software (e.g., InSight Publisher, ViewPoint, eCTD Reviewer, Documentum, etc.). Experience with Veeva is a plus.

Additional Requirements

• Self-starter with superior time management skills, and ability to work independently or in teams.
• High proficiency in Microsoft Word and Adobe Acrobat (specifically using "toolbox" plug-ins) is essential.
• Exceptional attention to detail.
• An interest in how software and standardized workflows can improve speed and compliance.
• Ability to explain technical submission requirements to non-technical team members.
• Fluency in English Language.

Compensation & Benefits

The anticipated salary range for this position is $115,000 to $140,000. Actual compensation may vary based on factors including experience, qualifications, skills, and business needs.

In addition to base salary, SK Life Science offers a competitive benefits package, including a 401(k) plan with company match and medical, dental, and vision coverage. Benefits are subject to eligibility requirements and may be modified at the Company's discretion.