Regulatory Affairs Professional (with Ukrainian)

Job Tasks:

• The responsibility of this person is to coordinate a broad range of product lifecycle changes (Regulatory Life Cycle Management) for countries in the assigned region (including Ukraine), from planning of the submission up to implementation of the change in the applicable databases and, if applicable, artwork.
• Coordinate lifecycle management procedures (mostly CMC variations and Labeling changes)  plus any other regulatory procedure as assigned.
• Coordinate procedures from planning (assignment in WebTcard system to a specific Life Cycle Management RA Professional) 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 or HA questions and prepare response documents/dossiers in alignment with EMEA Liaison, CMC-RA and/or LOC.
• Process HA approvals appropriately, to allow implementation steps and other post-approval activities to be initiated in a timely manner.
• Finalize/archive applicable documents/tools as soon as post-approval activities are completed, changes are implemented in artwork (if applicable) and databases are closed
• Perform all lifecycle management activities by following internal processes, templates and other applicable guidance documents implemented for the LCM team specifically or the European Regulatory team in general.

Requirements:

• Experience in regulatory affairs in pharmaceutical business (minimum 2 years)
• Good understanding of the pharmaceutical industry; regulatory experience in drug development and/or maintenance of marketed products
• Detailed knowledge of local regulations and guidance’s in the cluster/region related to full drug lifecycle; understanding of how these apply to specific projects and how to interpret them in the context of the scientific and commercial environment
• Awareness of the scientific principles (CMC, clinical and non-clinical) applicable to the specific products
• Knowledge of quality and supply chain and potential impact to regulatory procedures and status of products
• Very good English and Ukrainian language is a must
• Education within pharmacy, chemistry, medicine or biotechnology will be a plus.

Offer:

• Opportunity to work for a global leader in pharmaceutical and med-tech business
• Access to global know how and participation in EMEA based projects
• Benefits (full private medical care, life insurance, multisport)
• Remote or hybrid work model