Zurich, Switzerland
Reporting to the CEO. Manage the global activities of Quality and Regulatory Affairs ensuring the implementation of appropriate and effective regulatory strategies. Develop, manage and control the quality strategy, systems, plans, SOP’s, KPIs and ensure groupwide implementation. Lead the Corporate Quality Operations & Compliance for multiple manufacturing facilities including oral dosage forms and Injectables. Develop/coordinate/implement regulatory strategy through a global regulatory team approach for products to obtain in time approval by regulatory agencies. Provide expert advice to Product Development Teams and subsidiaries on regulatory issues as they arise with the developmental compounds or marketed products throughout the entire life cycle of the drug. Review and provide final approval Worldwide Marketing Applications and Clinical Study Reports
Providing consulting services for pharma industry on drug regulatory affairs from initial MAA through LCM, quality, pharmacovigilance and drug development. Projects include EU market access strategies for generics, hybrids and repurposed molecules, regulatory support for development of novel pharmaceutical forms, neutraceuticals, strategy development for XEVMPD, ISO-IDMP and FMD, Quality Assurance for sterile and OSD sites and international trade, GMP Turn around projects/ Remediation projects/ Dossier and Company Due Diligence
Reporting to the COO. Provide Regulatory strategy & support for Kowa Phase II and Phase III compounds up to and including new marketing authorization applications. Coordinate scientific advice meetings with regulatory authorities on development programs, clinical trial design in phase II and III and pediatric investigation plans. Align with Clinical Development teams to assure implementation of critical elements in the overall development plan. Align with Commercial, Market Access and Operations teams to align RA strategy with market entry strategy
Reporting to the CEO. Manage the global activities of Quality and Regulatory Affairs ensuring the implementation of appropriate and effective regulatory strategies. Develop, manage and control the quality strategy, systems, plans, SOP’s, KPIs and ensure groupwide implementation. Lead the Corporate Quality Operations & Compliance for multiple manufacturing facilities including oral dosage forms, topical, and Injectables. Lead the company’s inspection readiness projects for securing the approvals of different regulatory authorities with focus on getting US FDA and EMA approval for defined MS pharma affiliate facilities. Develop/coordinate/implement regulatory strategy through a global regulatory team approach for products to obtain in time approval by regulatory agencies. Point-lead for interfacing with Health Authority review teams and is a leader that facilitates approval of regulatory submissions and coordinates appropriate responses to Health Authorities with appropriate personnel and departments to resolve outstanding regulatory issues. Provide expert advice to Product Development Teams and subsidiaries on regulatory issues as they arise with the developmental compounds or marketed products throughout the entire life cycle of the drug. Review and provide final approval Worldwide Marketing Applications, Clinical Study Reports, protocols, Investigator Brochures before release from our company to external agencies and investigators
Reporting to the President Europe Operations. Providing strategic and operational input into the development of the Regulatory Affairs, Pharmacovigilance and Quality functions for Europe, setting up an infrastructure that allows Amneal to file marketing authorizations as well as remain compliant during life cycle management of its products. Defining strategies for regulatory submissions for obtaining and maintaining approvals for Amneal products in Europe. Proving feedback on clinical and quality requirements for Europe regarding the research and development of new products. Surveillance of new RA requirements for Europe and liaising with R&D and In-licensing on the impact of these on Amneal operations. Supervising the central and local Regulatory Affairs team members regarding submission of regulatory documentation and contact with local competent Health authorities