Regulatory Affairs Associate - Medochemie
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#ML43229 Type: Full time
Medochemie Ltd is a Cypriot pharmaceutical company with international exposure offering quality pharmaceutical products to patients in more than 100 countries worldwide. Medochemie manufactures and licenses a wide range of products produced at its 13, GMP-certified manufacturing facilities around the world and divided into more than 10 therapeutic categories.
Medochemie Ltd invites applications from career-oriented Regulatory Affairs Associate.
- To prepare CTD as well as eCTD format dossiers for new products and update the ones for existing products in compliance with the global regulations in force.
- To submit and oversee the attainment of Marketing Authorisations according to the company’s commercial strategy and considering the different country-specific requirements.
- To submit the necessary lifecycle management activities (renewals and variations) in all territories as necessary to maintain the company’s Marketing Authorisations while enabling the materialisation of the company’s evolving strategy.
- University degree in sciences (e.g. Chemistry, Biochemistry, Biology). A postgraduate degree will be considered an advantage. asset.
- Ability to work both individually and as part of a team, as well as prioritise work in a dynamic and fast-moving environment.
- Excellent interpersonal skills, analytical thinking and ability to work under pressure.
- Competency in Microsoft Office applications.
- Fluency in both written and spoken English.
- At least 2 years of experience within the pharmaceutical industry in the Field of Generic Regulatory affairs.
- Solid knowledge of Eur.Ph., EMA & ICH guidelines related to pharmaceutical product development and regulatory affairs.
- Competency in e-CTD preparation.
Location: LIMASSOL, CYPRUS
We are offering an attractive remuneration package based on the candidate’s experience and relevant qualifications as well as great opportunities for professional development.
If you wish to work in a pleasant, modern, professional environment with excellent career opportunities, please click Submit your CV or Fill in the online Form buttons below.
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