Dinah Jwad
Regulatory Affairs Manager
Grez-Doiceau
Profil professionnel
Experienced Regulatory Affairs Manager with expertise in pharmaceutical and medical product licensing, compliance, and marketing. Skilled in project management, regulatory strategy, and cross-functional collaboration. Organized, rigorous, and results-oriented.
Vue d'ensemble
13
13
years of professional experience
5
5
years of post-secondary education
Expérience professionnelle
Senior Specialist Regulatory Affairs
Bayer via Pharmalex
MONT SAINT GUIBERT
02.2019 - Actuel
- Managed worldwide regulatory renewals (Middle East, LATAM, Eastern countries).
- Developed regulatory strategies, ensured compliance, prepared submissions, and maintained regulatory databases.
- Prepared and maintained regulatory documents and submissions.
- Managed the review of promotional materials and labelling for compliance with regulations.
- Collaborated with cross-functional teams to ensure a seamless process for regulatory submissions.
- Liaised with regulatory authorities to resolve issues and provide timely responses.
- Provided guidance and support on regulatory activities to ensure compliance.
- Organized and maintained regulatory files and databases.
- Performed regular audits to ensure compliance with regulations.
Regulatory Affairs Manager
XPE Pharma and Science
WAVRE
07.2018 - 11.2018
- Training on REGULATION (EU) No 536/2014 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC
- Non projects were assigned during these four months!!
Senior Specialist/Coordinator Regulatory Affairs
MSD
BRUSSELS
06.2011 - 06.2018
- New marketing authorizations, compliance, labeling, and artwork.
- Supported clinical trial applications and collaborated cross-functionally on regulatory guidance.
- Performs timely and correct submissions and approvals of assigned new Marketing.
- Ensures that marketing authorizations are maintained in compliance with related regulatory areas, through performing the necessary activities, including variations and renewals, with a high standard and within the agreed timeframes and communicates approvals to stakeholders through the correct processes.
- For assigned products, ensures timely preparation and maintenance of local SPC, PIL, labelling, local physicians' circulars, packaging material and other applicable regulatory documents according to MSD and local standards and Artwork Management procedures.
General Secretary
LD Organization
LOUVAIN LA NEUVE
03.2010 - 09.2010
- Présentation de l'entreprise: Scientific Conferences
- Managed conference logistics and communication with international participants
- Scientific Conferences
Polyvalent Employee
Babylon Motors
BRUSSELS
04.2006 - 12.2008
- Welcoming customers.
- Invoicing, billing and filing letters and document.
- Negotiation, purchasing and buying used car.
- Canvassing to find new private and Professional customers.
Formation
Master de spécialisation - VETERINARY MEDECINE
Baghdad University
BAGDAD 01.1990 - 01.1995
Compétences
Regulatory systems
SAP/ AMS Bleu/ print connect
BRAIN/ ORION
Master Control/ e-learning
ShareDoc/ PharmDoss/ RCAM/ XEVMPD
BRAVE/ RIM
Automator/ CESP/ EUDRALINK
Informations complémentaires
- B
- A2
- Boat
Langues
French
Courant
English
Courant
Arabic
Courant
Dutch
Opérationnel
Italian
Intermédiaire
Personnalisé
- Fitness
- Spinning
- Sailing
- Motorcycling
Projets réalisés
- SME RA database ORION BELUX : contact person, generate reports, organise trainings sessions, escalade issues to global. KPI from 30% to 100%
- RIM : Analysis of business needs and translation into functional specifications, Coordinate analysis and activities with IT Project Manager, Ensure good communication with stakeholders in the project (verbally and written), Ensure the delivery of the Training Material when it's needed, Ensure review of training developed for newcomers on new solution.
Frise chronologique
Senior Specialist Regulatory Affairs
Bayer via Pharmalex
02.2019 - Actuel
Regulatory Affairs Manager
XPE Pharma and Science
07.2018 - 11.2018
Senior Specialist/Coordinator Regulatory Affairs
MSD
06.2011 - 06.2018
General Secretary
LD Organization
03.2010 - 09.2010
Polyvalent Employee
Babylon Motors
04.2006 - 12.2008
Master de spécialisation - VETERINARY MEDECINE
Baghdad University
01.1990 - 01.1995
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