Regulatory Affairs Specialist

by dejobs.org

Amadora

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 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