GSK Consumer Healthcare is looking for a Regulatory Affairs Associate (Romania & Moldova) to join its team in Romania!
The new colleague is going to be responsible for Regulatory Affairs in defined portfolio or activity stream within Romania & Moldova.
Responsibilities:
- Manage preparation of new regulatory documents and applications to enable new products to be launched and maintained in the market, with the correct alignment and compliance to regulations.
- Manage the maintenance of the current registered products (medicines, medical devices, cosmetics and food supplements) in line with the internal and external compliance requirements.
- Manage compliance within defined portfolio/activity stream in line with GSK CH expectations - support key processes and ways of working.
- Work together with other functions (e.g., marketing, supply chain) to deliver new products and value engineering projects.
- Actively contribute to the activity of the team, including looking for ways to improve the performance.
- Build relationships with key internal and external stakeholders and represent GSK in an appropriate manner according to company values, in order to present GSK Consume Healthcare (CH) policies and strategies.
- Proactively manage the impact of regulatory changes within defined scope of responsibility on the business.
- Maintain required regulatory compliance databases, systems and processes.
- Maintain high level of knowledge on the legislation and science of products within defined portfolio.
Requirements:
- Bachelor or master’s degree in Life science/Pharmaceutically related science (Pharmacy, Chemistry, Biochemistry, Biology, Medical Engineering).
- Ideally a minimum of 2 years’ experience in Regulatory Affairs .
- English – advanced level.
- Regulatory professional at this level must be highly skilled in scientific interpretation/ evaluation/ communication of technical information.
- Precision, proactivity and reliability in work.
- Good team player.
- Meeting deadlines and enable to coop with complex tasks.
- Ability to multi-task and work under pressure.
What we provide:
- GSK is a „MODERN EMPLOYER”, which provide a supportive working environment, development opportunities and competitive compensation packages designed to attract and to retain the very best.
- We are proud to promote an open culture, encouraging people to be themselves and giving their ideas a chance to flourish.
- A science-led global healthcare company that researches and develops a broad range of innovative medicines and brands.
- Our products are used by millions of people around the world, helping them to DO MORE, FEEL BETTER AND LIVE LONGER.
*LI-GSK
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