Regulatory Affairs Associate

Job description

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.

Job Duties

Duties:

• 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.

Job Requirements

Qualifications:

• 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.

Preferred:

• 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. 

Job Benefits

We are offering an attractive remuneration package based on the candidate’s experience and relevant qualifications as well as great opportunities for professional development.