Regulatory Affairs Associate 503 - Bucharest

Regulatory Affairs Associate 503
Bucureşti
Bucharest, Bucharest, Romania

Regulatory Affairs Associate 503

Product
Life Group is looking for Regulatory Affairs Associate join our dynamic team.

About us

Group 10 Responsibilities

To contribute to the production of client administrative documents to be included in regulatory submissions in Eurasia region

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
- 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 Product
Life Ltd’s Quality Management System

Group 11 Education

Bachelor’s degree in a science related field, or A levels with data entry experience

Group 12 Experience

Experience of 1-3 years of RA experience in the pharmaceutical or service industry

Knowledge in EU regulations

Group 13 Skills

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, e
DMS, MS Word, MS Excel

Good English Language and grammar skills (written fluency a must, verbal fluency preferred)

Informații detaliate despre oferta de muncă

Firma:	ProductLife Group
Localiția:	Bucureşti Bucharest, Bucharest, Romania
Adăugat:	24. 5. 2025 Postul de muncă activ

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Regulatory Affairs Associate 503 Bucharest

Regulatory Affairs Associate 503
Bucureşti
Bucharest, Bucharest, Romania

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Regulatory Affairs Associate 503 Bucharest

Regulatory Affairs Associate 503BucureştiBucharest, Bucharest, Romania

Locuri de muncă Bucureşti - locuri de muncă interesante în împrejurimi:

Bucureşti: Alte locuri de muncă în orașul tău

Regulatory Affairs Associate 503
Bucureşti
Bucharest, Bucharest, Romania