Informacje o stanowisku

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 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

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 departments 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.

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