Regulatory Labeling Manager
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Job Description
Regulatory Labeling Manager supporting Syneos Health’s life sciences clients with health-authority negotiations, safety-data interpretation, and eCTD labeling submissions.
Responsibilities:
- Support labeling negotiations with health authorities
- Interpret safety data and assess its impact on labeling
- Use structured content authoring tools or XML-based labeling systems
- Prepare labeling components for eCTD submissions
- Perform regulatory labeling activities within the Clinical Solutions team
- Collaborate with customers and cross-functional colleagues in Functional Service Provider or Full-Service environments
- Take initiative and challenge the status quo in a competitive and changing environment
- Undertake additional tasks, duties, and responsibilities as assigned
Requirements:
- Experience supporting labeling negotiations with health authorities
- Knowledge of safety data interpretation and its impact on labeling
- Familiarity with structured content authoring tools or XML-based labeling systems
- Experience preparing labeling components for eCTD submissions
- Typically 2+ years of experience in the biotechnology industry, preferably in Regulatory Affairs, Regulatory Labeling or a related discipline
- Minimum Bachelor's degree in a Science or Business-related field
- Equivalent experience, skills, and/or education will also be considered
Benefits:
- Career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition
- Total rewards program
- Inclusive culture
- Reasonable accommodations, when appropriate, for employees or applicants with disabilities
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