An exciting role has opened for a passionate regulatory affairs expert who would like to grow and develop their career towards post marketing projects globally if varied therapies.
• Coordinate, prepare or review regulatory submissions for all projects to include but not limited to new MAAs, variations and other associated life cycle maintenances submissions.
• Support and facilitate all life cycle maintenance activities with partner CROs
• Support assessment of change controls for the regulatory team
• Help with regulatory related questions and complaints
• Lead the artwork approval process of printed packaging components to meet packaging design and legislation requirements for each new product, new packs or changes to existing packaging
• Review labelling (SPC, PIL and Labelling) for compliance against current EU guidelines and standards
• Liaise with relevant internal and external suppliers/departments to assist with implementation being achieved effectively and on time.
• Coordinate review & approval of EU promotional material
• Maintain current knowledge base of existing and emerging regulations, standards or guidance documents
• Follow company policies and procedures
• Collaborate with team to establish and meet targets and timelines
• Help generate SOPs and Work instructions
• University degree in life science, pharmacy, pharmacology, medicine or related discipline and possible higher degree
• At least 3 years Regulatory Affairs experience
• Experience in filing new registrations via CP/DCP
• Experience in variations and life cycle management through European procedures (MRP/ National)
• Independent, reliable and communicative personality who can deliver high-quality work even under pressure and handle several projects simultaneously
Please send your CV
Michael Bailey International is acting as an Employment Agency in relation to this vacancy.