Regulatory Affairs & Quality Assurance for Adriatic and Balkan region – This role is based in Ljubljana Slovenia.
Omega Pharma is a Belgian-based pharmaceutical subsidiary of Perrigo Company plc.
Perrigo Company plc is a leading global healthcare supplier that develops, manufactures and distributes over-the-counter (OTC) and prescription (Rx) pharmaceuticals and nutritional products . The company is the world’s largest manufacturer of OTC pharmaceutical products for the store brand market and an industry leader in pharmaceutical technologies
Omega Pharma is one of the major companies in the consumer health and personal care industry in Europe.
With over $5 billion in sales and more than 12,000 people working around the world, Perrigo Company is a leading global healthcare supplier.
Omega Pharma, the Branded Consumer Healthcare division of Perrigo, has a wide brand portfolio including top brands like XLS Medical, Predictor, Davitamon, Galenco, Bodysol, Wartner, Etixx, Phytosun Aroms and Paranix. This portfolio has been expanded with international brands acquired from GlaxoSmithKline, like Solpadeine, Lactacyd, Beconase, Zantac 75mg, Abtei.
Omega Pharma a Perrigo Company has managed to build a high-performance, customer-focused organization which today is directly operating in 35 countries – mainly in Europe – serving a high potential market of prescription-free, consumer-oriented health products, with different legal status ranging from medicines, medical devices, cosmetics, food supplements and biocides.
Supervise all Regulatory Affairs activities in the Adriatic region
Make sure all relevant company and product licences are available and maintained
Support the New Product Development activities of the Corporate teams with country specific regulatory input
Manage due diligence for country specific product acquisitions
Supervise the individual country Quality Management System
Create access to Regulatory networks with Authorities and Key Opinion Leaders in the region
Maintain a high level of Regulatory intelligence on existing and developing regulations
Manage country audits and inspections in the region
Bachelor and/or Master degree in sciences (e.g. pharmacy, biology, chemistry, nutritional engineer)
At least 3 years of relevant experience in regulatory affairs
Knowledge of regulations for human medicinal products, medical devices, food supplements, biocides and cosmetics
A good knowledge in pharmacovigilance will be considered an asset
Genuine and autonomous leader
Clear communicator and solution oriented business partner
Strong project management and follow-through skills
Efficient team worker in a multicultural environment
Sound overall knowledge of the pharmaceutical/consumer goods market in Bulgaria and good understanding of how Regulatory Affairs can contribute to the development business strategy
Fluent in English language
A key Regulatory Affairs & quality Assurance position for an ambitious and energetic professional
An appealing career opportunity in a dynamic, strong growing multinational environment
Apart from a competitive remuneration pack we offer personal development and growth opportunities