Lifecycle Labeling Lead—Regulatory Affairs

Syneos Health; Lisboa; Presencial; EUR 55 000 - 75 000; Tempo integral

Resumo da oferta

Syneos Health is seeking a Regulatory Labelling Manager for Lifecycle Products to develop, maintain and oversee labeling content for mature pharmaceutical products. This role involves authoring and updating labeling documents in response to safety updates, regulatory requirements and internal assessments.

You will collaborate with internal stakeholders to ensure governance is followed and labeling decisions are well-documented in accordance with Sponsor's Labelling Procedures.

Qualificações

• Experience supporting labelling negotiations with health authorities.
• Knowledge of safety data interpretation and its impact on labelling.
• Familiarity with structured content authoring tools or XML-based labelling systems.
• Experience preparing labelling components for eCTD submissions.
• Typically 2+ years of experience in biotechnology, Regulatory Affairs or related discipline.
• Minimum Bachelor's degree, in a Science or Business-related field.

Responsabilidades

• Develop, maintain, and oversee labeling content for mature pharmaceutical products.
• Author and update labeling documents in response to safety updates, regulatory requirements, and internal assessments.
• Collaborate with internal stakeholders to ensure governance processes are followed and labeling decisions are well-documented.

Conhecimentos

Labelling negotiations

Safety data interpretation

XML-based labelling

eCTD submissions

Formação académica

Bachelor's degree in Science or Business

Ferramentas

XML-based labelling system

Descrição da oferta de emprego

Syneos Health is seeking a Regulatory Labelling Manager for Lifecycle Products to develop, maintain and oversee labeling content for mature pharmaceutical products. This role involves authoring and updating labeling documents in response to safety updates, regulatory requirements and internal assessments.

You will collaborate with internal stakeholders to ensure governance is followed and labeling decisions are well-documented in accordance with Sponsor's Labelling Procedures.