Regulatory Affairs Consultant / Project Manager-US Agent (West Coast)

Parexel currently has an excellent opportunity for a Regulatory Affairs Consultant / Project Manager with previous experience managing small/mid-sized projects at the IND/NDA/BLA maintenance stage coupled with previous experience representing clients as a US Agent.

This Home-Based position is part of our growing Regulatory Consulting Services Team and offers an amazing opportunity to join an industry leader in a field that continues to see tremendous growth and opportunity!

As a Regulatory Affairs Consultant / Project Manager you will: Coordinate multi-disciplinary project teams and manage the day-to-day operations of domestic and international Regulatory projects Strive to achieve operational excellence through on time delivery of projects that are within budget and to the highest quality with the goal to exceed client expectations Provide guidance on FDA requirements Interact with the FDA on behalf of clients for regulatory matters Remain aware of relevant FDA regulations and apply such knowledge/guidance to projects Serve as a designated Regulatory Contact or US Agent for clients which may include: Assisting FDA in communications with the foreign company who wishes to market pharmaceutical products or medical devices in the US, Responding to questions concerning the foreign establishment's products or devices that are imported or offered for import into the United States, Assisting FDA in scheduling inspections of the foreign establishment and If FDA is unable to contact the foreign establishment directly or expeditiously, FDA may provide information or documents to the U.S. agent, and such an action shall be considered to be equivalent to providing the same information or documents to the foreign establishment. QualificationsSuccessful candidates will have: At minimum, possess an undergraduate degree in a clinical or health related field, advanced degree preferred Previous Regulatory Affairs related experience in a Life-Sciences Consulting Firm, a Biotech or Pharmaceutical company, or experience as a Project Manager at the FDA or other Health Authority 3-5 years previous experience managing cross-functional Regulatory projects to include previous experience managing the preparation, organization, and submission of FDA regulatory applications ie. INDs, BLAs, NDAs & all regulatory documents/submissions critical to product life cycle. Knowledge of FDA processes and regulations Experience in communicating (verbal/written) with the FDA Global regulatory experience is a plus Employment is contingent on disclosure of your COVID-19 vaccination status and, if relevant, proof of vaccination.

EEO DisclaimerParexel is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.