Responsibilities:
1. Project managing product life cycle regulatory issues including post marketing variations, amendments, renewals, etc. including all associated technical pharmaceutical studies
2. Lead reg team member of project team for new product development.
3. In conjunction with existing staff supporting the preparation of dossier files for marketing authorisations including Part 1/Admin sections, Part 2 CMC pharmaceutical sections including technical/scientific input on studies & creating and overseeing studies needed for pharmaceutical sections of dossier preparation
4. In conjunction with the quality team – Providing technical and regulatory input to quality & QA for documentation associated with existing product manufacture
5. Liaise as needed with CMO’s on regulatory matters, change controls, regulatory filing matters including studies for new licences or variations, change controls, and audits for regulatory compliance
6. Facilitate project status meetings and other meetings as required
7. Develop strong relationships with all stakeholders to create high-functioning global project teams
8. Establish project plans with associated milestones and deadlines
9. Identify, document, and facilitate resolution of project risks and issues
10. Oversee routing, tracking, and archiving of project documentation
Qualifications:
11. Possess the requisite expertise regarding the regulatory requirements for the Pharmaceutical Sector in the European Union demonstrated by a diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognized as equivalent by the Member State concerned in, engineering or another relevant scientific discipline,
12. Four years of professional experience in regulatory affairs or in quality management systems
13. Ability to work independently and complete multiple assignments on time Knowledge and/or experience in International registrations and clinical studies is a plus.
Salary is open to negotiation depending on qualifications and experience. If you are interested please apply or email