Regulatory Affairs Specialist

Detalhes da Vaga

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 Twitter, Facebook, Instagram, YouTube 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 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 communicationKnowledge of information management and database administrationAdditional 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 this link.

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more.
#J-18808-Ljbffr


Salário Nominal: A acordar

Fonte: Jobleads

Função de trabalho:

Requisitos

Legal Back-Office Advisor (English-Speaking) - Airline Company

.Experience the power of a game-changing careerAre you looking for what's next? We're a global technology and services leader that powers the brands of the f...


Concentrix Portugal - Lisboa

Publicado a month ago

Legal Back-Office Advisor (German-Speaking) - Airline Company

.Experience the power of a game-changing careerAre you looking for what's next? We're a global technology and services leader that powers the brands of the f...


Concentrix Portugal - Lisboa

Publicado a month ago

Contract Specialist

.Purpose of PositionThe Contracts Specialist plays a critical role in the accurate and timely execution of NetJets Agreements to ensure the successful closur...


Netjets Europe - Lisboa

Publicado a month ago

Legal Counsel

.The Vision-Box World...Join us on our exciting journey and become part of our innovative future!At Vision-Box, you are empowered to be innovative, creative ...


Vision-Box - Lisboa

Publicado a month ago

Built at: 2024-11-14T01:59:23.871Z