Job #: 47138
Title: Regulatory Affairs
Job Location: Scottsdale, Arizona - United States
Remote Job: Unknown
Salary: contact recruiter for details
Other Compensation: Bonus, stock
Employer Will Recruit From: Regional
Relocation Paid?: NO
WHY IS THIS A GREAT OPPORTUNITY?
Growning company, just went IPO! Great team! JOB DESCRIPTION
- Responsible for assuring that projects are assigned to internal or external team members to meet departmental goals, FDA timelines, and to ensure the team adequately functions to meet all company objectives.
- Perform in depth reviews and approvals of labeling and submission documents, for quality, content, and accuracy, prior to final disposition.
- Hands on leader in regard to daily work load; in addition to managerial responsibilities, this position could have independent work assignments to manage on behalf of the team, if needed, as well as participate in the preparation of all NDA submission documents including handling CMC, labeling, PADER, supplements, annual reports and 510Ks.
- Establish/maintain a tracking database to capture all assigned pre- and post-approval labeling projects.
- Work to ensure submissions are reviewed and transmitted to FDA on-time while following the Electronic Common Technical Document (eCTD) requirements.
- Prepare responses to FDA deficiencies pertaining to submissions, as necessary.
- Attend project meetings to ensure labeling timelines are met and provide labeling updates to the project team for those products being discussed.
- Provide guidance and leadership with regard to best practices in the labeling arena.
- Maintain a metric of all team projects for reporting purposes.
- Create, train, and/or revise Standard Operating Procedures (SOPs), as appropriate.
- Develop PowerPoint presentations for training or informational purposes to senior management.
- Maintain knowledge of regulations, guidelines, and SOPS applicable to prescription labeling.
- Participate in continuous improvement efforts related to business practices and tools utilized within the role.
- Prepare and submit Annual Reports for all the approved products.
- Prepare and submit labeling supplements for approved products.
- Review and approved various CMOs change requests.
- Review Structured Product Labeling (SPL) for team projects to ensure product data elements align with the required drug listing regulations and established SPL is submitted through FDAs Electronic Submission Gateway, upon application approval, for timely posting to DailyMed in order to meet launch readiness, maintain current labeling content on DailyMed, and FDA NDC directories.
- Responsible for archival of the electronic submission documents in the product specific files.
- Prepare the eCTD compilation of NDAs, 510Ks and other supplements (PAS, CBE-30, CBE).
- Responsible for the maintenance of Establishment Registration for all facilities.
- Prepare citizens petitions and controlled correspondence with FDA, as necessary.
- Prepare annual PDUFA information requests and facilitate payments.
- Act as liaison with Office of Prescription Drug Promotion (OPDP) for assigned marketed products to facilitate the FDA review of advertising and promotional materials (e.g. launch materials submitted for advisory).
- Ensure a highly effective and efficient review and approval process for advertising and promotion materials and the timely and accurate submission of branded materials to OPDP in compliance with FDA regulations.
- Perform all other job related duties as required by management.
- Bachelors in Pharmaceutical Sciences, Masters preferred
- 2-7 years of experience in regulatory, in pharmaceutical and/or medical device industry is needed to perform the current functions
- Regulatory Affairs Certificate is a plus
- Ability to handle multiple projects, motivated to grow in a fast-paced working environment
- Must be proficient in applicable computer and database applications including MS Word, MS Excel, PowerPoint and Adobe Acrobat Professional (PDF).
- Must be well organized, detail oriented, have the ability to multi-task and manage changing priorities.
- Demonstrable applicable knowledge in FDA regulations and FDA guidelines are also required.
- Demonstrable acceptable skills in oral and written communications, independent judgement, problem solving and effective managing and adhering to timelines.
University - Bachelor`s Degree/3-4 Year Degree
How to Apply: