Posted in Compliance 30+ days ago.
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Type: Full Time
Location: Louisville, Kentucky
Supports regulatory department with cross-functional projects, submission requirements, and specific regulatory and development initiatives as required.
DUTIES AND RESPONSIBILITIES:
The following reflects management s definition of essential functions for this job but does not restrict the tasks that may be assigned. Management may assign or reassign duties and responsibilities to this job at any time due to reasonable accommodation or other reasons: * Serves as a Commercial RA representative on project teams, as assigned.
* Supports regulatory lead personnel in preparing new product marketing submissions for the FDA as required (NDA, ANDA, BLA, & related supplements).
* Supports the assembly of content for periodic reporting requirements to include marketing application annual reports and investigational new drug annual reports under the direction of regulatory lead personnel.
* Commercial RA representative in labeling discussions; draft/edit labeling; prepare labeling submissions; and archive labeling for future revisions and annual reports
* Researches, compiles, and interprets information as required to support company regulatory initiatives with a focus on promotional material, tradename development, and labeling development projects.
* Coordinate the compilation and submission of all periodic safety reports for all approved products.
* Tracks progress and deadlines of multiple projects under the direction of a regulatory lead.
* Supports information requests from regulatory agencies.
* Supports regulatory senior management in the development of contracts and verification of invoicing and deliverables against agreed terms.
* Prepares and reviews content for cover letters, relevant background and any questions for regulatory bodies to accompany the company s regulatory applications (e.g. INDs, NDAs, as applicable).
* Prepares and reviews content for responses to FDA requests for information.
* Develops and maintains working knowledge of regulations/guidances/regulatory landscape for focus area.
* Researches and compiles data for regulatory department as requested to support other project requirements.
* Contribute to the development and implementation of regulatory processes and procedures.
* Trains on and maintains responsibility for other regulatory department duties as assigned (e.g. assistance with preparation of state pharmacy board license applications, assistance with upkeep of regulatory budget tracking, and/or department invoice coding).
* Assists submissions personnel in maintenance of Regulatory Affairs documentation, as required.
* Minimum Bachelor s Degree in Life or Engineering Science, advanced science or medical related degrees desirable
* Experience within a regulated or pharmaceutical environment.
* Proficient writing and strong organizational skills required.
* Must be able to complete and prioritize multiple projects simultaneously.
* Demonstrated communication and human relation skills.