Regulatory Affairs Officer, Lisbon (Portugal)

A World's leading Pharmaceutical Services Company is looking for a Regulatory Affairs Officer to assist senior regulatory staff in the preparation or review of submissions regarding preclinical or clinical studies. This position is based in Lisbon, Portugal.

Responsibilities:

*Prepares and/or reviews regulatory documentation in area of expertise, as appropriate.
*Establishes relationships with many customers.
*Understands the Scope of Work, deliverables and management of budget for any given project and manages workload as appropriate.
*May give guidance to junior colleagues, including feedback on the quality of technical documents, and may assist in their training and development.
*May present to clients on complex regulatory processes at large full service bid defence meetings by phone or in person.
*May act as reviewer for regulatory SOPs, as assigned and appropriate.
*May prepare and deliver regulatory training to small groups or individuals.
*Performs other tasks or assignments, as delegated by Regulatory management

Qualifications/Skills:

*Life Science Degree
*2 or more years of experience as Regulatory Affairs Officer in CRO, pharmaceutical or regulatory agency environment
*Solid technical/regulatory writing skills
*Ability to work independently with minimal supervision
*Ability to work on several projects at once
*Strong software and computer skills, including MS Office applications
*Fluent in Portuguese and in English, both written and verbal.

My client offer career opportunities providing flexibility and growth across the organisation with high international projection, competitive salary and benefits package, work-life balance initiatives and social events.

If you would to discuss this role in greater detail or your application / suitability to this or further roles, please call me or email me in confidence. If you are not available or suited to this position, please feel free to pass my details on.

For a confidential consultation call Esther Manrique on 0044 (0) 207 255 6665 or email your CV to [Email hidden]
"1st IT/Pharma People are acting as an Agency and or Employment Business"

Key words: regulatory affairs, regulatory associate, regulatory officer, ICH-GCP, ICH, SOP's, SOPs, SOP, Standard Operating Procedure, pharmaceutical, CRO, processos regulamentares, assuntos regulamentares, investigação clínica, Indústria farmacêutica