Zaměstnavatel: nabízí volné pracovní místo na pozici: Principal RA Operational Executive (ref.: 1-14-87381/ID)

To prepare high quality documentation for all regulatory submissions (focusing on life cycle maintenance) with minimum supervision (using company software for eCTD preparation and conversion); liaising with relevant departments to ensure regulatory requirements for these submissions are met; proactively communicating with regulatory authorities in order to expedite approval of these submissions.

Span of control

This position is intended to cover the following areas :
•eCTD submissions
•Life cycle maintenance


Role and Responsibility
•To prepare and submit high quality documentation for all regulatory submissions, following current best practice standards
•To liaise with relevant internal epartments and external contacts to ensure regulatory requirements for these submissions are met and to proactively communicate with regulatory authorities in order to expedite approval of submissions
•To prepare all registration documentation in eCTD (using company software Extedo) and act as publisher for all company submissions
•To be responsible for RA departmental procedures and initiatives to improve process / efficiencies, particularly the use of IT.
•Develop and manage appropriate tracking tools for EU RA department – life cycle maintenance section taking a full responsibility for submissions in timely manner and implementation of all changes to manufacturing sites
•To prepare and maintain product labelling for appropriate markets in co-operation with local regulatory and commercial contacts.
•To anticipate and resolve regulatory issues with focus on life cycle maitenance
•To actively participate as primary regulatory resource in cross-functional project teams
•To prepare and review plans for submissions within agreed timelines and ensuring alignment with agreed strategy (life cycle maintenance)
•To develop and populate the Regulatory databases including regular maintenance
•To prepare and manage “change control” business cases for all RA variations and changes, submission to change control committee and managing whole process of preparation, submission and implementation of variations
•To provide information on expenditure against budget for inclusion in monthly financial reports
•To maintain the paper and electronic filing system for their products/countries, following Records Retention procedures


Work generation

•By Self – 30%
•By Immediate superior –70%

Požadavky

•University degree.(Degree in life sciences will be preferred)
•2-3 years of regulatory experience with at least 1 year if direct involvement in life cycle maintenance and compilation of dossier in eCTD
•A full strategic understanding of the drug development principles and processes
•Demonstrates an ability to analyse and summarise data to a high level
•Focuses on customer needs, follows up on commitments and requests.
•Excellent interpersonal skills
•Excellent verbal and written communication skills (CZ, EN)
•Able to work effectively without much supervision
•Knowledge of Microsoft office and ability to work with company software (Extedo for eCTD compilation, publishing)

Ostatní

If you want to apply for this job, please, send us your curriculum vitae in English with the ref. number in subject of your application.

If you've had an interview in Grafton already, please, contact your consultant directly (ideally by email).



For more related job opportunities visit www.grafton.cz/pharma/


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Plat

55000,- CZK/m