Regulatory Affairs Specialist

2 meses atrás

Amadora, Portugal AbbVie Tempo inteiro

**Company Description**
- Ensure maintenance of Marketing Authorisations (CP, MRP/DCP & NP) of medicinal products and Medical Devices registrations, through variations and other regulatory submissions, including label, artwork and local prescribing information.
- Review Promotional and Non-promotional materials, to ensure compliance with local legislation and corporate requirements.
- Ensure artwork development of all package components, in accordance with implementation dates.
- 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.
- Write and update local procedures in compliance with the local regulation and internal policies and procedures, if applicable, and implement its training in the affiliate.
- Provide regulatory support for the affiliate in all areas pertaining to product life-cycle management and new product development and introduction.

**Qualifications**
- Life sciences Degree (e.g. Pharmacy)
- A minimun 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

**Additional Information**

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

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