Regulatory Affairs Consultant Safety/Labelling
Poland, Remote Additional Locations: Bucharest, Bucureşti, Romania 职位编号 R0000026952 类别 Consulting关于这个职位
Are you an experienced regulatory professional looking for a new opportunity? We are currently seeking a Regulatory Affairs Consultant - Safety/Labelling to join our dynamic team! This is a client dedicated project, and the role can be office or home based in various European locations.
Key responsibilities will include:
Acting as expert for labelling-related activities
Providing strategic labelling guidance and/or input in regulatory impact assessment, submission preparation and execution
Developing, supporting and reviewing labelling and/or safety-related content
Creating and maintaining the CCDS; leading and coordinating CCDS updates, coordinating and overseeing the implementation of updates into local labels
Advising on the regulatory requirements for labelling updates in different global regions e.g. EU and ROW.
Experienced in managing responses to regulatory authoring questions and negotiating company positions with regulatory authorities
Skills and experience:
Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline, Advanced Degree Preferred
3-5 years of experience in an industry-related environment
Previous experience working in the pharmaceutical industry in support of Global Labelling or in a Regulatory (Clinical / Safety) role
Experience interacting with a regulatory authorities
Critical thinking and problem-solving skills
Project leadership and management knowledge
Excellent interpersonal and intercultural communication skills, both written and verbal
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