Regulatory Affairs Specialist

il y a 2 semaines

Bruxelles, Région de Bruxelles, Belgique AmerisourceBergen Temps plein

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Regulatory Affairs Specialist

Apply locations Brussels, Belgium WEMEA > Belgium > Brussels > Weiveldlaan - BRU time type Full time posted on Posted 4 Days Ago job requisition id R253674

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today

Job Details

Pharmalex, is a Cencora company.

Pharmalex is looking for a Regulatory Affairs Specialist to be responsible for the management of Regulatory Affairs requiring specific scientific experience and skills in the health products sector in line with the requirements of European and Benelux regulations.

This is a hybrid role based in Belgium, with the expectation of 2 days a week minimum to be spent in the Mechelen office.

Key Responsibilities:

  • Improve knowledge of applicable legislation.

  • Stay up to date with scientific developments relevant for the portfolio of the clients.

  • Manage the dossiers individually and in cooperation with other countries where submissions are required.

  • Prepare regulatory dossiers ensuring compliance with the regulations in force and commitments made to clients.

  • Prepare submission of European dossiers in eCTD format (CP, MRP/DCP, renewals).

  • Be the lead for some client contacts, managing client needs.

  • Be actively involved in internal meetings with Pharmalex and demonstrate pro-active behaviour.

  • Participate in audits or diagnosis of dossiers.

  • Submit PSUR/PSUSA.

  • Manage packaging and labelling activities.

  • Participate in achieving activities.

  • Comply with quality procedures.

Critical qualifications and experience:

  • Successful completion of Pharmacist's diploma or a scientific Master's degree (in Regulatory Affairs), or in some cases a specialized bachelor's degree.

  • Dutch and French Fluency.

  • Strong English skills.

  • German language would be beneficial but not essential.

  • Knowledge of European regulatory requirements for medicinal products is desirable.

  • Distinctly strong service orientation.

  • Ability to manage one or several activities with limited guidance.

  • Independent approach to work, flexibility and dedication.

  • Diplomacy, ability to communicate and integrate in an international and multicultural environment.

  • Strong sense of responsibility, organizational skills and intrinsic motivation.

  • Ability to manage internal and external (client) relationships on an operational/day-to-day working level.

  • Good knowledge of the MS-Office package.

  • Good communication skills (written and verbally); capability to communicate issues and propose solutions.

What Cencora offers

Benefit offerings outside the US may vary by country and will be aligned to local market practice. The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements.

Affiliated Companies: AmerisourceBergen Services Corporation

Equal Employment Opportunity

Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national

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