Provide support to regional marketed products. Provide regulatory post-launch guidance for products to optimize regulatory compliance, commercial decision making and revenue generation. Responsible for identifying, implementing, and revising regulatory strategies for assigned projects, to ensure success for all products.
Collaborates with International Markets Regional and Country Commercial groups, Portfolio, R & D, Quality, and TGO as appropriate to ensure alignment of activities, plans, strategies, and outcomes
Provide regulatory advice to project teams to ensure the inclusion of regulatory concerns in relevant data planning and production to achieve the project objectives.
Assist in the development of multi country regulatory strategy and update strategy based upon regulatory changes
Advise teams on regulatory requirements for changes to marketed products.
Compilation and preparation of the IM Renewal Work Plan for Gx/OTC and track execution KPI.
Collaborate closely with all other key Global Regulatory Affairs stakeholders, including other Regulatory Teams and Regulatory Affiliates, in order to ensure that all aspects of the Regional Strategy is observed and implemented.
Monitoring and support of Renewal activities according to the planned timelines
Maintenance and update of the Post approval regulatory Database
Keeps acquainted of new regulations, standards, policies, and guidance issued by relevant regulatory authorities that may affect the company.
Product change management activities – risk assessment and evaluation.
Special projects impacting all IM: Divestments, MA lists/cancellations.
An Associate’s degree in Biology, Biotechnology, Life Sciences, or Health Sciencesרפואה ופארמה
מנהל רגולציה ומע’ איכות | רפואה ופארמה
A minimum of 7 years of experience in (Gx) RA or a regulated healthcare environment.
International Markets country experience – a plus
Working knowledge of Microsoft Office applications; ability to learn/use TEVA RA systems
Strong analytical skills
Excellent oral and written skills
The ability to learn on the job in a dynamic environment
Project Management Skills; able to handle multiple projects and work items effectively
Collaborative, can drive work individually and can work effectively with a team to deliver results
משרה מספר 6684760