Regulatory Labelling Specialist - India - Apsida Life Science

Description

Senior / Labelling Specialist

Job Description:

We are seeking a highly skilled and experienced Senior Labelling Specialist to join our team and take on a pivotal role in the development and approval of labelling documents for our vaccine portfolio. As a Senior Labeling Specialist, you will be responsible for overseeing all aspects of labeling, from initial document preparation to coordination with regulatory agencies and senior management. This role requires a deep understanding of regulatory requirements, strong leadership abilities, and excellent communication skills to collaborate effectively with cross-functional teams.

Key Responsibilities:

Labelling Document Preparation:

• Draft and finalize corporate, US, and EU labelling documents, including prescribing information and patient information, for developmental, mature, and marketed products within the vaccine portfolio.
• Ensure compliance with regional regulatory guidelines and requirements while maintaining consistency and accuracy in labelling content.

Contribution to Regulatory Strategies:

• Provide expertise in labelling to contribute to the definition of global regulatory strategies.
• Interpret regulatory requirements and ensure that labelling strategies align with broader regulatory objectives and corporate goals.

Submission Dossiers and Responses:

• Play a key role in preparing submission dossiers and responses to Health Authorities, focusing on labelling-related aspects to ensure accuracy, compliance, and strategic alignment.

Leadership of Labelling Working Group (LWG):

• Lead a multidisciplinary LWG comprised of representatives from Global Regulatory Affairs, Pharmacovigilance, Medical Affairs, Legal, Communications, preclinical, and CMC.
• Facilitate collaboration, knowledge sharing, and alignment across functional areas to drive labelling-related initiatives forward.

Coordination with Senior Executive Management:

• Coordinate the presentation of LWG proposals to Senior Executive Management through a Labelling Review Committee.
• Prepare presentations, synthesize input from the LWG, and facilitate discussions to obtain senior management approval for labelling strategies and documents.

Support for Transversal Projects:

• Provide labelling expertise and support for transversal projects that have implications for labelling or require labelling input.
• Collaborate with other functional teams to ensure that labelling considerations are integrated into broader initiatives such as product launches and lifecycle management