Regulatory Affairs Specialist II
3 months ago
To support RA associates in all administrative activities related to registration, electronic submission, maintenance of Drug Master Files (DMF) and answering customers' requests.
How you’ll spend your day- 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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