Lead and manage multiple commissioning / qualification / validation activities performed at facility with minimal supervision. Equipment Qualification / Re Qualification (IQ, OQ, PQ) for process equipment, QC equipment, packaging equipment, clean utilities. Cleaning Verification / Validation studies for transferred products. Media Fills / process simulations protocols. En

Responsible for PV Safety function for all Ferring Investigational and approved products. Responsible for Adverse Event and Medical Device Reporting for all Ferring Investigational and approved products. Serve as Deputy Local Safety Officer responsible for Pharmacovigilance safety function in the US. Responsible for management of safety case reporting Provide Pharmacovigi

Manage Regulatory Affairs, Advertising & Promotion and Compliance Group Manage the US RA Ad Promo, submission operations, labeling and compliance group staff, including objective setting and career development activities and motivate line reports to achieve shared and individual goals. Regulatory Leadership of Advertising and Promotional Materials Serve as subject matter