Regulatory Affairs Specialist - 872

In the context of our growing activities, we are looking for a Regulatory Affairs Specialist to join our teams in Ukraine.

Responsibilities

Assisting with the preparation of Marketing Authorisation Applications
Assisting with license applications as required.
Preparation and submission of documentation for post-approval applications including, but not limited to, Type IA, Type IB, Type II, BSVs, Renewals, MAH Transfers/COAs
Preparation and submission of Technical/Site Transfer Applications
Monitor and maintain up-to-date knowledge of national and European guidelines/legislation.
Ensuring compliance with all regulatory processes, in readiness for both internal and external audits.
Use a variety of software packages to produce correspondence and documents, maintain spreadsheets and databases, and locate information and data eg Microsoft Office Suite, Veeva (or comparable EDMS), LorenZ, Trackwise etc
General regulatory administration duties and compliance requirements
Management of artwork generation
Providing support during external and unannounced audits.

Bachelor’s degree or more in a Life Sciences related field.
At least 5 years of experience in Regulatory Affairs in the Pharmaceutical Industry or via a Service Provider
Previous experience in a consulting company would be a plus

Hard/Technical skills:

Native Ukrainian mandatory along with fluent English
Deep knowledge of Ukrainian RA regulation for pharmaceuticals (NCE, Biologicals and Biotech) and Medical Devices
Experience in regulatory lifecycle maintenance activities for drug products (Renewals, PI updates, technical variations)
Strong computer skills, including MS Office applications, data and document management systems (Veeva or comparable EDMS, LorenZ, Trackwise, etc)
Experience of promotional/non-promotional activities would be an advantage

Soft skills:

Excellent organizational skills
Effective oral and written communication skills
Ability to work well within a team
Process oriented with good attention to detail
Ability to prioritize different workloads/multi-task
A proven ability to consistently deliver to tight timelines, without negatively impacting on the quality of the work
Solution-driven