Senior Regulatory Affairs Associate 564

We are seeking for a Regulatory Affairs Officer responsible for ensuring the delivery of regulatory activities performed onsite.

Responsibilities

To contribute to the production of client administrative documents to be included in regulatory submissions
Compile regulatory dossiers in accordance with national requirements.
Systems Management and Administration
Document and track regulatory submissions and regulatory authority approval.
Provide regulatory support to clients and associate companies.
Liaise with external regulatory authorities as required.
Provide review of packaging texts.
Provide format review of Summary of Product Characteristics, Patient Information Leaflets and labelling (e.g. QRD compliance check).
Provide on-going regulatory support to the Regulatory Affairs Manager and to project teams to ensure regulatory concerns are planned and accounted for and the relevant data are generated to meet project objectives.
Contribute to data entry in PLG tools enabling measurements of KPI, metrics for regulatory services supplied by the platform/hub
Assist in the preparation of Standard Operating Procedures (SOPs) and Working Practice Documents (WPDs).
Assist in the management of ProductLife Ltd’s Quality Management System.

Bachelor’s degree in a science related field, or A levels with data entry experience
Experience of 1-3 years of RA experience

Excellent organizational and interpersonal skills
Ability to work well within a team
Process orientated with good attention to detail
Effective oral and written communication skills
Good computer skills and the ability to learn appropriate software
Good understanding of regulatory tracking database software, eDMS, MS Word, MS Excel
Good English language and grammar skills (written fluency a must, verbal fluency preferred)
Good speaking level in German
Hungarian language is a plus