Regulatory Affairs Consultant Safety/Labelling
Client:
Parexel
Location:
Ireland
Job Category:
Other
EU work permit required:
Yes
Job Reference:
8bc3f28502e9
Job Views:
5
Posted:
06.02.2025
Expiry Date:
23.03.2025
Job Description:
When our values align, there's no limit to what we can achieve.
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:
1. Acting as expert for labelling-related activities
2. Providing strategic labelling guidance and/or input in regulatory impact assessment, submission preparation and execution
3. Developing, supporting and reviewing labelling and/or safety-related content
4. Creating and maintaining the CCDS; leading and coordinating CCDS updates, coordinating and overseeing the implementation of updates into local labels
5. Advising on the regulatory requirements for labelling updates in different global regions e.g. EU and ROW.
6. Managing responses to regulatory authoring questions and negotiating company positions with regulatory authorities
Skills and experience:
1. Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline, Advanced Degree Preferred
2. 3-5 years of experience in an industry-related environment
3. Previous experience working in the pharmaceutical industry in support of Global Labelling or in a Regulatory (Clinical / Safety) role
4. Experience interacting with regulatory authorities
5. Critical thinking and problem-solving skills
6. Project leadership and management knowledge
7. Excellent interpersonal and intercultural communication skills, both written and verbal
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