A Regulatory Affairs, Business oriented professional, with extensive expertise in the pharmaceutical regulatory field.
Excellent Project Management skills, capable of delivering key communications with clarity, impact and passion.Ability to lead and offer creative solutions to regulatory problems, while balancing the expectations of Health Authorities.Ability to Recognise potential long term issues for projects..
-Collaborated with local and global stakeholders to submit and successfully register new medicinal products, as well as maintain existing marketing authorisations and notifications, in line with local requirements and global standards. Ensure timely and compliant regulatory submissions.
-Coordinated of different activities and responsibilities in order to perform various regulatory processes (Clinical Trial Application and amendments, packaging and labelling, and Supply Chain issues).
-Secured new business opportunities by cultivating strong relationships with potential clients.
-Developed strategic partnerships for sustained growth.
-Performed new regulatory strategies to reach new business opportunities.
- Maintained updated dossiers for the products commercialized in more than 80
countries.
-Reviewed regulatory and quality documentation for CMC department,
- Performed change control work packages for CMC changes.
-Conducted DCP, MRP, RUP, and National procedures in almost all member states within the EU for more than 50 international companies from the pharmaceutical sector.tical
sector.
-Conducted national procedures in non-European countries, with experience in the management of CPPs, GMPs for third countries, and certificates for the supply of products manufactured in the EU, legalisations, and apostilles.
-Interacted with different health authorities within the EU and non-EU countries.
- Carried out training sessions in GMP, GDP, GSP.
-Performed customer service support regarding quality complaints.
-Regulatory compliance
-Drug development knowledge
-Packaging and labelling
-Project management
-Cultural awareness
-Efficient multitasking
-Operational leadership
-Strategic planning