PURPOSE AND SCOPE:

Assists in the support of the daily operational activities within Regulatory Operations for the preparation of regulatory submissions required to market new or existing licensed pharmaceuticals products in the domestic and international markets as assigned. Maintains systems designed to ensure compliance with electronic submission requirements and document management systems. In addition to publishing responsibilities, this role will lead and support the creation, implementation, and ongoing maintenance of departmental Standard Operating Procedures (SOPs), Work Instructions (WIs), and operational processes, ensuring alignment with evolving regulatory requirements, internal standards, and best practices. . 

PRINCIPAL DUTIES AND RESPONSIBILITIES:  

Serves as a seasoned regulatory operations professional with a comprehensive understanding of global submission requirements and processes; applies creative problem-solving to resolve a wide range of technical and operational issues.

Manages the end-to-end preparation, compilation, publishing, quality control, validation, and delivery of electronic regulatory submissions (eCTD) in compliance with global Health Authority requirements and internal standards.

Supports submission planning and execution for initial marketing applications and post-approval lifecycle submissions (e.g., supplements, variations, renewals) across multiple regions including the U.S., Canada, EU, and Asia-Pacific.

Performs thorough QC reviews to ensure submission-ready documents meet formatting, technical, and regulatory standards.

Collaborates cross-functionally with Regulatory Affairs, CMC, Medical Writing, Quality, and other stakeholders to ensure timely and accurate handoff of components for inclusion in submissions.

Interprets and applies key regulatory guidance, regional submission specifications, and evolving eCTD requirements (including ICH, FDA, EMA, etc.).

Leads and contributes to the development, revision, implementation, and training of departmental SOPs, WIs, and standardized publishing processes to ensure consistency, efficiency, and regulatory compliance.

Assists in the management and continuous improvement of templates, procedures, and tools used to support global submission activities.

Troubleshoots technical issues related to publishing tools and document formatting, particularly within MS Word and Adobe Acrobat, and supports resolution of validation errors.

Participates in evaluating and implementing new regulatory technologies; ensures alignment with infrastructure standards and supports transitions from legacy systems to electronic platforms.

Maintains compliant archival and storage of regulatory documents, ensuring alignment with regulatory and business needs.

May mentor junior staff, provide publishing guidance, and act as a resource for complex submissions.

Demonstrates strong organizational and time management skills with the ability to manage multiple priorities under tight deadlines.

Ensures compliance with all applicable regulations, company policies, and the Code of Business Conduct.

May escalate complex issues for resolution and assist with additional projects or duties as assigned.

Assist with various projects as assigned by a direct supervisor.

Additional responsibilities may include focus on one or more departments or locations.  See applicable addendum for department or location specific functions.

PHYSICAL DEMANDS AND WORKING CONDITIONS:

The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential function

EXPERIENCE AND REQUIRED SKILLS:         

Bachelor’s Degree required; Advanced Degree desirable

Minimum five (5) years of regulatory operations experience in the pharmaceutical or biotechnology industry, with a strong emphasis on global regulatory submissions.

Proven expertise in the preparation, compilation, publishing, and validation of eCTD submissions in support of U.S. (FDA), Canada (Health Canada), EU (EMA, MHRA), and Asia-Pacific (PMDA, TGA, NMPA, etc.) regulatory requirements.

In-depth knowledge of electronic publishing tools and Regulatory Information Management (RIM) systems.

Proficiency with electronic document management systems (EDMS) and advanced knowledge of document formatting tools, particularly MS Word (template and style management) and Adobe Acrobat (PDF optimization and troubleshooting).

Strong understanding of global regulatory submission guidance.

Demonstrated experience managing multiple submission projects in parallel, with proven ability to meet tight deadlines and deliver high-quality, technically compliant outputs.

Strong organizational skills and meticulous attention to detail; able to identify and resolve issues independently and proactively.

Excellent written and verbal communication skills, with the ability to clearly document processes, communicate submission requirements, and collaborate effectively across teams.

Experience with electronic submissions, specifically eCTD, required.

Strong understanding of document management processes in a regulated pharmaceutical environment.

Demonstrated understanding of the drug development process and project management experience is highly preferred.

Proven experience in developing, revising, and maintaining departmental Standard Operating Procedures (SOPs), Work Instructions (WIs), and internal processes, with a focus on continuous improvement and regulatory compliance.

Strong software troubleshooting skills.