EU Regulatory Manager
An exciting opportunity has arisen for an EU Regulatory Affairs Manager in Switzerland. In this role you will be responsible for leading and implementing regulatory activities for assigned projects.
- 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.
- Manage and facilitate all life cycle maintenance activities with partner CROs
- Review 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.
- Maintain relationships with print suppliers and the artwork studio
- 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
- Identify, design and implement process and system improvements
Skills and Requirements
- University degree in life science, pharmacy, pharmacology, medicine or related discipline and possible higher degree
- Experience in filing new registrations via CP/DCP
- Experience in variations and life cycle management through European procedures (MRP/ National)
- Experience in Labelling & artwork management
- Experience in project management
- Literate in Microsoft Office applications
- Independent, reliable and communicative personality who can deliver high-quality work even under pressure and handle several projects simultaneously
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.