Manager, Regulatory Operations

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.
• Affords assistance in the formatting and "publishing" of documents to ensure they meet eCTD (Electronic Common Technical Document) standards.
• Might represent RegOps in cross-functional teams, such as product, project and/or regulatory submissions teams; offering 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.
• Helps 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.
• Affords assistance 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.

Pay & 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.