Regulatory Affairs Specialist
Há 2 dias
Join AbbVie's Team of Regulatory Experts
AbbVie is a leading pharmaceutical company dedicated to discovering and delivering innovative solutions for serious health issues. As a Regulatory Affairs Specialist, you will play a crucial role in ensuring the maintenance of Marketing Authorisations and Medical Devices registrations.
Main Responsibilities:
- Ensure maintenance of Marketing Authorisations (CP, MRP/DCP & NP) of medicinal products and Medical Devices registrations, through variations and other regulatory submissions.
- Review Promotional and Non-promotional materials, to ensure compliance with local legislation and corporate requirements.
- Liaise with national regulatory authorities to obtain optimal outcomes for patients and AbbVie's portfolio as required.
- Maintain awareness of current and new legislation/guidance and ensure that work is in compliance with all relevant statutory requirements and all relevant internal procedures.
Requirements:
- Life sciences Degree (e.g. Pharmacy)
- A minimum of 5 years of experience in Regulatory Affairs in the responsibilities mentioned above (both Medicinal Products and Medical Devices)
- Previous experience in Pharmaceutical Industry (Affiliate role)
- Fluency in English, both in oral and written communication
- Knowledge of information management and database administration
About AbbVie
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion.
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