Regulatory Affairs Generalist
Berkeley Heights, NJ 07922
The Manager Regulatory Affairs (Operations and Submissions Management) is responsible for the electronic assembly, routine planning, publishing, submission and archiving of regulatory submissions for new drug/biologics in the US and North America. This position ensures adherence to best practices with regard to early stage submission to the FDA. The candidate is expected to proactively review new regulations related to electronic submissions and prepare working instructions and SOPs as needed. Additionally, this position demonstrates expert Regulatory publishing skills, and working knowledge of electronic document management practices, and a knowledge of the early stage drug development processes.
Responsible for global/local electronic document management system (EDMS), and expected to become local Subject Matter Expert with the process and system and train other Regulatory staffs as needed.
Responsible for planning, publishing, compiling, tracking, and archiving regulatory documents and submissions (e.G., DSURs, IBs, Annual Reports, Safety Reports, Amendments, FDA Briefing Books, etc.)
Ensures accurate formatting of regulatory submission to support acceptance of filing. Reviews and assesses documents related prior to regulatory submissions.
Supports Regulatory Affairs personnel in the coordination, preparation and submission of INDs and regulatory documents (FDA briefing documents) in electronic publishing systems.
Liaises with Regulatory Affairs and applicable line functions (e.G., IT) for problem resolution and ensuring agreed action is implemented.
Expert, working knowledge of the changing FDA guidelines regarding electronic submissions and submission data standards. Assesses impact of standards and requirements and prepares working instructions/SOPs to meet these changes.
Assists in communication and coordination activities with global project team members as well as development partners.
Adherence to submission timelines, health authority publishing specifications, and internal working practices. Technical verification of regulated documents via workflows within electronic document management systems.
Responsible for all US archiving requirements. Evaluates and makes recommendations for improvement where needed, creates and implements improvement plans when possible.
Responsible for managing and testing of Regulatory Plans for submissions, including verifying and documentation to ensure US compliance
Significant experience with electronic submissions publishing system, software and tools (i.E., Documentum, docuBridge, MS Words, Adobe Acrobat, etc.) and FDA s Electronic Submission Gateway (ESG)
Experience with the preparation eCTD documents and review of US IND submission
Knowledge of IND, eCTD requirements and related guidelines is required
Working knowledge of TMF governing regulations and maintain all regulatory
documentation in the TMFs.
A minimum of a Bachelor s degree in life science or related fields with at least 2 years of both Regulatory Submission Management/Operations and Pharmaceutical industry experience required