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Your responsibilities include but not are limited to:

• Manages medium to small level global regulatory submission projects. Provide submission and contribute to the technical related regulatory strategy, intelligence and knowledge required to develop, register, and maintain global products.
• Managing projects end to end to define regulatory strategy for the regulatory submissions where required. Identify content, quality and/or timelines issues with source documents, or any other potential authoring issues that may impact submission quality or timelines, as early as possible.
• Identify the required documentation for regulatory submissions and negotiate the delivery of approved source documents in accordance with project timelines.
• Author high-quality CMC documentation (dossiers) as per Regulatory guidelines, applying CMC regulatory strategies (wherever needed), assuring technical consistency and regulatory compliance, meeting defined timelines and e-CTD requirements.
• Developing professional expertise, applies company policies & procedures to resolve a variety of issues. Frequent internal company and external contacts. Represents organization on specific projects. Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors. Refers to established policies & procedures for guidance.
• Keep knowledge up to date with regard to regulatory guidelines and requirements in all global regions as well as for new technical trends.
• Actively participate as a member of the global Reg CMC team by contributing to the regulatory strategy, identifying the critical issues and lessons learned. Establish and maintain sound working relationships with stakeholders, partners, and customers.