Regulatory Affairs Specialist

Primary purpose and function of this position:

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

Duties and Responsibilities:

• 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.

Job 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
• Initiative
• Self-motivated
• Time management
• English - good professional level, both in writing and speaking
• Previous experience of working in a pharma company/regulation (advantage)