Teva Regulatory Affairs Specialist II 

Israel, Center District 

844321143

To support RA associates in all administrative activities related to registration, electronic submission, maintenance of Drug Master Files (DMF) and answering customers' requests.

• Prepare and maintain electronic submissions (eCTD) of DMFs, via a publishing system, according to industry guidelines.
• Submission of DMFs, prepared by RA team, to authorities according to relevant guidelines.
• Routine support and collaboration with the Regulatory Affairs Associates team members in administrative activities related to submissions and technical preparation of DMFs.
• Answering and supporting customers' requests by providing administrative information (DMFs, CEPs, Deficiency letters responses prepared by RA team) and additional categories as needed, via CRM.
• Filling RA documents in CRM and Smarteam systems.
• Distribution of costumer notifications prepared by RA team via the CRM system.
• Learning of submission regulatory guidance and internal work processes
• Working with several submission systems in parallel and different gateways according to authority's requirements.

Capabilities:

• Good human communications
• High service approach to internal & external customers
• The ability to adapt to new ways of working and learn new processes.
• Organized
• Technical skills
• Individual work ability as well as teamwork
• Meeting work target timelines
• Readiness to work when required
• Ability for self-learning
• Initiative
• Self-motivated
• Time management
• English - good professional level, both in writing and speaking
• Former experience working in a pharma company/regulation (advantage)

Education;

• University degree in science (B.Sc.)

Regulatory Affairs Manager

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