Manager, Regulatory Affairs
Description ESSENTIAL JOB FUNCTIONS
Provide support for work performed on INDs, sNDAs and NDAs
Provide support in compiling routine submissions, including but not limited to: annual reports, labeling submissions, OPDP submissions, meeting requests, SPL, and investigator updates
Work directly with outside vendor to ensure timely publishing of materials and submission to drug applications
Perform QC checks on published submissions, ensuring all data for submission are complete and in compliance with company guidelines and FDA regulatory requirements, such as eCTD format and submission hierarchy.
Track submissions to ensure all timelines are met; notify Regulatory Affairs staff of pending submissions
Responsible for working cross-functionally on labeling by tracking, ensuring implementation, and submitting changes to existing labeling to FDA
•Work cross-functionally to ensure Regulatory comments are incorporated into promotional materials prior to production
Provide support to project teams as directed to meet filing objectives and department needs
Completion of assigned tasks with a high level of quality within departmental and company timelines
Other duties as assigned, which may include assisting other functional areas, on an as needed basis
EDUCATION AND EXPERIENCE
BA/BS degree or equivalent experience in related field preferred
3+ years of experience working in regulatory affairs/operations
Knowledge of FDA regulations and guidances
Excellent verbal and written communication skills
Excellent attention to detail (including proofreading skills)
Outstanding interpersonal and effective task planning / coordination skills
Strong teamwork, negotiation and influencing skills
Advanced computer skills in a Windows environment, including Microsoft Office, Adobe Acrobat, and EDMS. Experience with regulatory publishing programs preferred.
SKILLS AND ABILITIES
Comprehension: Ability to understand opposing points of view on highly complex issues and to negotiate and integrate different viewpoints.
Decision Making: Ability to make decisions which have impact on the department's credibility, operations, and services.
Communication: Ability to formulate complex and comprehensive materials such as legal documents, authoritative reports, official publications of major scope and impact, etc and to make formal presentations.
Mathematics: Ability to compute, analyze, and interpret numerical data for reporting purposes.
Ability to learn on the go and obtain the skills needed to work within a technical environment
Strong communication and organization skills with attention to detail (including proofreading skills)
DEPOMED COMPETENCIES INCLUDE
Decisions and Judgment: completing assigned tasks by gathering relevant information systematically and considering a broad range of issues or factors when making decisions.
Ownership and Initiative: Assumes personal ownership and accountability for business results and solutions. Organizes work based on company/department goals. Develops alternative strategies when confronted with obstacles. Plans and organizes work so that timelines are met or exceeded.
Communication skills: Expresses ideas and information effectively and constructively. Provides accurate and timely information to others within the department and across functional groups. Demonstrates attention to and understanding of others' comments, questions, and views.
PHYSICAL/MENTAL DEMANDS PHYSICAL DEMANDS:
Sitting - 80%
Standing/ walking - 20%
Repetitive motion: Substantial movements of the wrists, hands, and or fingers for sustained periods of time. Approximately 6-hours of keyboarding per day.
Visual Requirements: Able to see and read PC screens and read fine print.
Lifting: Raising objects under 15 pounds from a lower to a higher position or moving objects horizontally
Ability to understand, remember, and apply oral and/or written instructions or other information
Ability to understand, remember and communicate routine, factual information
Ability to organize thoughts and ideas into understandable terminology
Ability to organize and prioritize own work schedule
Able to complete forms, use existing form letters and conduct routine oral communication
Able to compose letters, outlines, memos and basic reports, and to orally communicate technical information
Ability to count accuratelyResponsible for supporting regulatory activities for Depomed's marketed products and those in development. Responsible for supporting the Regulatory Affairs function in all areas of Regulatory, including submissions to INDs, NDAs and sNDAs, advertising & promotion, and labeling, including but not limited to preparation of submissions, proofreading, working on cross-functional teams, and performing research.