Regulatory Affairs Trainee, 4-hour shift within the working day for 12 months

GlaxoSmithKline is one of the world's largest research-based pharmaceutical companies. With more than 90,000 employees world-wide, the company is one of the industry leaders, committed to improve the quality of human life by enabling people to do more, feel better and live longer. GlaxoSmithKline Consumer Healthcare Bulgaria is among the leaders in the Bulgarian Oral care and OTC category and has been recognized as the Best Employer in the Pharmaceutical sector in Bulgaria. It is now looking for motivated professional to join the team at the position of:

Regulatory Affairs Trainee, 4-hour shift within the working day for 12 months
Location: Sofia

This position has responsibility for Regulatory Affairs in defined portfolio within Bulgaria.

• Support preparation of new regulatory documents, dossiers and applications to enable new products to be launched and maintained in market, with the correct alignment and compliance to regulations, proactively seeking innovative and rapid path to market.
• Maintain required regulatory compliance databases, systems and processes.

• Ensure products are maintained and meet internal and external compliance requirements.
• Actively contribute to the activity of a high performing local team, including looking for ways to improve the performance.
• Maintain high level of knowledge on the science of products within defined portfolio.
• Maintain an up to date knowledge on and apply legislation relevant to regulatory affairs (National and relevant European Union legislation).

Qualifications & Experience:
• Mandatory: Graduating in Pharmaceutically-related science (Chemistry, Pharmacy, Biochemistry, Biology) or Medicine-last two years of study
• Previous experience in Regulatory Affairs would be an advantage

• English - advanced level
• Analytical thinking and attention to details;
• Good technical skills
• High level of organizational skills and prioritizing;
• Pro-active attitude;
• Problem solving skills ;
• Good team player – works well in cross-functional teams;
• Ability to work under pressure;
• Works with a spirit of continuous improvement and innovation, creatively open to new ideas and ways of working;
• Ability to self-motivate and be resilient and focused under pressure.

If you are interested in this internship position, send your application (CV and motivation letter) to: