Regulatory Affairs Associate
Middle (2-5 ani), Senior (5-10 ani)
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AbbVie is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world.
For our team in Bucharest we are looking for a Regulatory Affairs Associate.
- Regulatory content management and submission to Romanian Drug Agency,
- Ensure compliant medicinal product lifecycle management,
- Labelling (SmPC, PIL, packaging, artwork) content and compliance management,
- Ensure prompt and accurate translations,
- Liaison with internal logistics, commercial, corporate groups and external authorities,
- Keeping abreast of emerging legislation, providing impact analysis.
- Pharmacy or life-sciences degree (or equivalent),
- Experience in Regulatory Affairs,
- Knowledge of pharmacovigilance and/or quality assurance would be considered an advantage,
- Analytical and conceptual capabilities, solid prioritization and problem-solving skills,
- Excellent negotiation skills and ability to communicate with clarity,
- Positive individual with excellent interpersonal skills,
- Fluent written and spoken English,
- Proficient computer skills.