A

Regulatory Affairs Specialist

icon building Empresa : Abbvie
icon briefcase Tipo de Emprego : Periodo Integral

Número de Aplicantes

 : 

000+

Click to reveal the number of candidates who applied for this job.

Descrição do Emprego - Regulatory Affairs Specialist

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on TwitterFacebookInstagramYouTube and LinkedIn

Job 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

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.  It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html 

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

https://www.abbvie.com/join-us/reasonable-accommodations.html

Original job Regulatory Affairs Specialist posted on GrabJobs ©. To flag any issues with this job please use the Report Job button on GrabJobs.
icon no cv required CV Não Necessário icon fast interview Entrevistas rápidas por Chat

Compartilhe essa vaga com os seus amigos

Similar Empregos em Portugal

Compartilhe essa vaga com os seus amigos

O GrabJobs é o portal de empregos número 1 em Portugal, conectando você rapidamente a milhares de empregos de ! Encontre os melhores empregos de em Portugal, candidate-se com apenas 1 clique e consiga um emprego hoje!

Aplicativos de Celular

Copyright © 2024 Grabjobs Pte.Ltd. All Rights Reserved.