ERMC Specialist

Currently, for our client, an international company from the pharmaceutical industry, we are looking for a person to join the international Regulatory Affairs Team. 

what we offer

• employment contract for 12 months with the possibility of extension
• hybrid work (2 days a week remote work)
• benefits package: medical care, multisport card, life insurance
• work in an international environment

your tasks

•  Coordinate lifecycle management procedure in-scope of team, plus any other   regulatory procedure,
•  Coordinate procedures from planning through to global dispatch, submission, HA   approval and implementation in the applicable databases and artwork, where   applicable,
•  Ensure timely submission of a good-quality (response) dossier,
•  Manage validation issues  and prepare response documents,
•  Involve team colleagues for specific process steps like completion of databases   etc.,
•  Perform all country specific activities as described in the country requirements   database,
•  Perform all lifecycle management activities by following department's processes,
•  Act as mentor for new LCM colleagues,
•  Lead projects for LCM and/or act as a subject matter expert,
•  Ensure regulatory compliance of the RA lifecycle management activities and participate in audit-readiness activities where required.

what we expect

• A minimum of a University degree or equivalent by experience,
• At least 3 years of regulatory affairs experience,
• In depth knowledge of local and regional regulations/legislation,
• Experience in regulatory lifecycle management and in co-operation with HAs,
• Experience in working with limited supervision and able to make independent decisions,
• Excellent verbal and written communication skills,
• Proficiency in written and spoken English,
• Good knowladge of Ukrainian language,
• The following experience is seen as an advantage
•     Working in a virtual environment,
•     Experience in a regional/global organisation,
•     Experience in a local affiliate organization,

Employment agency entry number 47

this job offer is intended for people over 18 years of age