Regulatory Affairs Specialist CEE (Maternity Cover)

We are looking for а RA Specialist CEE to join Alvogen’s Regulatory Affairs team. This is a maternity cover contract position based in Sofia.

Responsibilities:

• Initiate, coordinate and supervise the registration of medicinal products from the company portfolio through European procedures (MRP, DCP, CP) or national procedure;
• Provide support documentation for the new applications in line with the in force European regulations and /or local pharmaceutical laws depending on the submission type and market;
• Ensure that all responses to authorities’ requests are correct, complete and timely submitted;
• Communicate with third parties in order to expedite submissions and ensure regulatory compliance;
• Provide input and advice for local regulatory teams and cross functional teams on relevant regulatory aspects;
• Ensure that accurate and complete information is timely provided to other departments/third parties;
• Inform the relevant functions on the status and progress of assigned projects in order to meet the set objectives, identify potential problems or delays, and possible solutions, as they occur;
• Maintain the current knowledge of applicable legislation within the responsibility area in line with the most up-to-date provisions;
• Ensure that the internal regulatory database and trackers are kept up-to-date;
• Perform regular reviews of the information available in the internal regulatory database

Job profile:

• At least 3 years Regulatory Affairs experience
• EU procedures experience is highly recommended for this position
• English language: advanced level, both speaking and writing; good understanding of English professional terminology
• Computer skills: very good knowledge of MS Office tools
• Chemist/ Biologist/Biochemist/Pharmacist

https://www.jobs.bg/job/4749749