Regulatory Affairs Specialist 502 - Bucharest

Regulatory Affairs Specialist 502
Bucureşti
Bucharest, Bucharest, Romania

Regulatory Affairs Specialist 502

We are seeking for a Regulatory Affairs Specialist with Project Management Skills who will be responsible for ensuring the delivery of regulatory activities performed in the platform/hub:

About us

Group 10 Responsibilities

To contribute to the production of client administrative documents and reports to be included in regulatory submissions

Compile, or supervise the compilation of regulatory dossiers in accordance with national requirements

Systems Management and Administration

Document and track regulatory submissions and regulatory authority approval

Gain regulatory authority approval

Provide regulatory support to clients and associate companies

Assess regulation and inform the clients about the impact on their products or activities

Liaise with sponsor
- office and affiliate departments on regulatory issues. Liaise with external regulatory authorities as required

Provide format and contents review of packaging texts, Summary of Product Characteristics, Patient Information Leaflets and labelling

Review tasks for, support and mentor Regulatory Affairs Associates

Provide
- going regulatory support to the Regulatory Affairs Team Lead 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 and metrics for regulatory services supplied by the platform/hub

Control that invoicing is correctly set

Assist the RA Platform or Hub Leader or Coordinator in presales:

Ensure providing technical support to presales

Ensure adequate technical description of the proposals and support sales for quotation evaluation

Ensure that invoicing is done correctly

Group 11 Profile and Skills

Master or higher graduate degree in a science related field, or equivalent experience along with experience in Project management or Coordinator skillset

Min 10 years of experience in a regulatory affairs department required + relevant experience in EU regulations

Strong coordination skills and leadership

Client communication and facing experience

Excellent communication skills in English (written fluency a must, verbal fluency preferred)

Excellent organisational and interpersonal skills

Good computer skills and the ability to learn appropriate software

Good understanding of regulatory tracking database software, e
DMS, MS Word, MS Excel

Ability to work well within a team

Process orientated with good attention to detail

Sense of responsibility and meeting deadlines

Pro-active attitude and able to work on own initiative as well as part of a team

Ability to prioritise different workloads/multi-task

Personal responsibility for ensuring a high standard of work

Detalii privind locul de muncă:

Firma:	ProductLife Group
Localiția:	Bucureşti Bucharest, Bucharest, Romania
Adăugat:	26. 10. 2022 Postul de muncă activ

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