▷ [Apply in 3 Minutes] Regulatory Labelling Specialist

3 weeks ago


Delhi, India Apsida Life Science Full time
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

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