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)

• Master's degree in Science, Chemistry, Life Sciences, or related field
• 3-5 years of experience in pharmaceutical regulatory affairs or related field

Make Your Mark with TAPI

Your journey with TAPI is more than a job—it’s an opportunity to make a lasting impact on global health. If you’re ready to lead, innovate, and inspire, we’re excited to welcome you to our team. Together, let’s shape the future of pharmaceuticals. Apply on top of this page and our talent acquisition team will be in touch soon!