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
- 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.
- 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
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