Search Results: 6 vacancies
...solving abilities;
Strong ability to carry out different projects and work under pressure while meeting timelines
Good knowledge of ICH guideline, applicable European Medicines Agency (EMA), Health Canada and Food and Drug Administration (FDA) regulations/guidelines....
...affairs, with a focus on international markets.Â
~ Strong understanding of global regulatory requirements and processes, including FDA, EMA, Health Canada, and other major regulatory agencies.Â
~ Experience with regulatory submissions and approvals in multiple countries.Â...
...requirements.
Key Skills:
In-depth knowledge of validation principles, practices, and regulatory requirements (e.g., USFDA, WHO, EMA, ICH).
Excellent communication and interpersonal skills, with the ability to collaborate effectively across diverse teams.
Strong...
...within Actuation - MEA portfolio. This position is responsible for leadership, execution, and professional direction of the Aerospace FMC EMA technology software development, in support of the Hydraulic and EMA strategy. Candidate will support the research and investigation of...
...related field
Experience in the pharmaceutical or biotechnology industry is a plus
Experience with regulatory agencies such as FDA or EMA is a plus
A successful candidate will possess the ability to work in a fast-paced environment and manage multiple competing...
...quality assurance processes in a pharmacovigilance setting.
· Experience with pharmacovigilance regulations and guidelines, including FDA, EMA, and ICH requirements.
· Familiarity with safety databases (e.g., ARGUS, ARISg, or similar) and adverse event reporting systems.
·...
