Global Regulatory Affairs eCTD Publishing Associate

PURPOSE AND SCOPE:

Assists in the support of the daily operational activities within Regulatory Affairs for the preparation of regulatory submissions required to market new or existing licensed pharmaceuticals and device products in the domestic and international markets as assigned.

Maintains systems designed to ensure compliance with electronic submission requirements and document management systems. 

PRINCIPAL DUTIES AND RESPONSIBILITIES:  


* A seasoned, experienced professional with a full understanding of Regulatory Affairs; resolves a wide range of issues in creative ways.


* Responsible for the preparation, compilation, quality check and delivery of regulatory submissions in both paper and/or electronic format in accordance with regional requirements and company standards.


* Works closely with contributing functional departments to ensure understanding of requirements and handoff of submission components in the appropriate format.


* Prepares interpretative analyses of key regulatory guidance documents related to submissions.

Interprets local electronic submissions regulations.


* Assists in implementing and maintaining various departmental guidelines, procedures and templates associated with the regulatory document management system, regulatory information system, and electronic submissions.


* Compiles, publishes, QC, and validates documents for FDA submission.


* Troubleshoots document issues in MS Word and Adobe Acrobat.


* Works with department and external groups as assigned.


* Evaluates and provides input for new department technologies and collaborates with intra-departmental resources to ensure adherence to infrastructure standards.


* Participates in the development of standards and processes in support of efficient submission development, review, approval and archival.


* Supports the transition from legacy to electronic submissions.


* Coordinates with regulatory staff to compile regulatory submissions.


* Ensures that all required documents are received and formatted appropriately and in a timely manner.


* Demonstrates knowledge of electronic submission requirements and prepares for future initiatives and requirements.


* Aligns document access and storage with RA electronic submission needs.


* May provide assistance to junior level staff with more complex tasks that require a higher level of understanding of functions.


* May escalate issues to supervisor/manager for resolution, as deemed necessary.


* Mentor other staff as applicable.


* Review and comply with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations.


* Assist with various projects as assigned by a direct supervisor.


* Other duties as assigned.

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