Regulatory Affairs Specialist
- Experience Level
- Experienced (non-manager)
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.
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