Manager, Regulatory Operations

Overview:

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.

 

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