Details: Title : Director of Regulatory Affairs Location: South plainfield, NJ Position type : PermanentJob Summary: As a Director of Regulatory Affairs you will draw on your regulatory experience and scientific background to support global registrations of all the products lines, existing and new for client. You will report to VP of Clinical Development and working closely to be responsible for developing the global regulatory strategy for assigned products, in order to obtain the optimal product label and shortest time to approval by regulatory agencies. Independently manages projects within assigned drug candidate functioning as the single, accountable, global point of contact on those projects. You will provide international regulatory and product development advice on the development and commercial production of biological and drug products. You will ensure the company is aware of the international regulatory requirements, to ensure compliance and to help develop business strategies and clinical trial management initially in the Middle East, Central, Latin, and South America, Asia as well as the European nations. Job Responsibilities include but are not limited to: - Supporting Ex-US Regulatory activities for biological development products. - Support Clinical Development work, products from phase I, II & III and beyond. - Liaising with international teams and with outside affiliates. -Writes and review technical documents for regulatory submission to various agencies. - Responsible for regulatory review and final approval of all submissions and associated documentation. - Provides expertise as worldwide regulatory representative to Product Development teams
No comments:
Post a Comment