Regulatory Affairs Specialist

• Development and implementation of a successful regulatory strategy for the EU clients.
• Submission of new Marketing Authorization, variation and renewal applications for EU countries via MRP, DCP, NP in eCTD format using relevant eCTD software.
• Preparation of Module 1 documentation (including Product Information) for all above mentioned applications and responses to Deficiency Letters (DLs).
• Liaise closely with EU Regulatory Authorities.
• Collaboration with internal and external parties and customers and coordination of all activities required for collection of all necessary information and documentation for compilation of Module 1 and responses to DLs.
• Participation in teleconferences and meetings with the Regulatory Authorities, suppliers, clients.
• Follow up of applications and maintenance of internal databases.
• Monthly reporting to BD department.
• Keeping abreast of EU pharmaceutical legislation, guidelines, and practices.
• Participation in the training of new RA team members.
• Coach, guide and review deliverables of RA Specialists.

Requirements

• Minimum of a BSc Degree in Pharmacy, Chemistry, Biology or another relevant field.
• 5+ years of relevant exper...