US Regulatory TA Strategy Develop and execute US regulatory strategy, with oversight as needed, and in conjunction with Global Regulatory Lead (GRL), Global Regulatory Team and Global project teams. Partner with the GRL to understand the competitive landscape, e.g., views of US HAs, regulatory precedents, labeling differences and TA specific issues. Utilize US regulatory

Manages all BU and brand needs from a SFE perspective in supporting sales teams (5), Market Access/Trade, KAS (1) KAMs (2) and MSLs Develop a strong understanding of sales strategies including sales force effectiveness initiatives, customer segmentations, affiliations/alignments, engagement activities and surface insights to key stakeholders Mentor and onboard new users o

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

Partner with Market Access and Finance teams to understand and map current models, processes, and data structures. Lead the business requirements gathering during the explore and discovery phases. When necessary, you write design decisions, driving cross team alignment. Mediate the information exchange between program team and business stakeholders to ensure that each req

Provide technical and mechanical support on all GMP and Non GMP utility systems Perform hands on routine and non routine activities for all GMP and Non GMP utility equipment and systems. Perform Corrective Maintenance (CM) on direct impact equipment/systems, including RODI, WFI, boilers, biowaste system, clean steam system, industrial HVAC, and compressed gases and CM on

Responsible for all aspects of facilities mechanical and electromechanical piping system such as water supply, compressed air, plant steam, waste treatment, Life Safety systems, Clean Utilities operations (pure steam, USP water, WFI). Oversees the activities of hourly Maintenance employees providing technical training, development and may support feedback on annual perfor

Independently provide compliance guidance on promotional and non promotional materials, scientific exchange, disease state, medical/scientific programs and R&D activities to minimize company risk and facilitate compliance that is in alignment with applicable regulations. Develop and execute an engagement and integration plan in symphony with other Compliance Associate Dir