Job Summary
We are seeking a highly skilled Regulatory Affairs Manager to lead our team in ensuring compliance with regulatory requirements for the Pharmaceutical Sector in the European Union. The ideal candidate will have a strong understanding of EU regulations and experience in managing projects related to product life cycle, dossier preparation, and quality management systems.
Responsibilities:
* Project manage product life cycle regulatory issues, including post-marketing variations, amendments, renewals, and associated technical pharmaceutical studies;
* Lead the regulatory team member of project teams for new product development;
* Collaborate with existing staff to prepare dossier files for marketing authorisations, including Part 1/Admin sections and Part 2 CMC pharmaceutical sections, providing technical/scientific input on studies and overseeing study creation;
* In conjunction with the quality team, provide technical and regulatory input to quality & QA for documentation associated with existing product manufacture;
* Liaise with CMO's on regulatory matters, change controls, regulatory filing matters, and audits for regulatory compliance;
* Facilitate project status meetings and other meetings as required;
* Develop strong relationships with stakeholders to create high-functioning global project teams;
* Establish project plans with associated milestones and deadlines;
* Identify, document, and facilitate resolution of project risks and issues;
* Oversee routing, tracking, and archiving of project documentation.
Qualifications:
* Possess 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;
* Four years of professional experience in regulatory affairs or in quality management systems;
* Ability to work independently and complete multiple assignments on time, with knowledge/experience in International registrations and clinical studies being a plus.
What We Offer:
A competitive salary package open to negotiation based on qualifications and experience.