Regulatory Affairs Officer – São Paulo

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Technical Skills/Experience
Degree in life science-related discipline or professional equivalent
Regulatory lifecycle maintenance experience, focusing on marketed products
Experience in regulatory procedures in Europe and/or emerging markets (e.g. variations/renewals/aggregate reports) Experience in new MAA applications in Europe and/or emerging markets an advantage
Good understanding of pharmacovigilance activities relevant to marketed products
Preferably has experience in managing regulatory projects
Interaction with Regulatory Agencies (EU/EMA)
Involvement in regulatory strategy and determination of documentation requirements, timelines, budgets
Preparation of relevant CTD documents to support submissions (mainly Module 1), in collaboration with technical/CMC/Labelling experts
Experience in quality review of technical/ regulatory documents
Able to assist in review and revision of regulatory SOPs / act as reviewer as appropriate

Soft Skills
Excellent verbal and written communication skills in English are essential
Well organised
Be able to manage peaks of workload and prioritise workload with some supervision
Ability to work to tight timelines
Open and communicative personality
Good team player
Good negotiating skills
Ability to identify issues and contribute to their resolution
Strong computer skills, including MS Office applications, data and document management systems
Adaptable to change
Cultural awareness

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