Regulatory Affairs Associate

Key Duties and Responsibilities:
* Provide technical and strategic product development and regulatory advice on products currently under development in product pipeline
* Research and analyse scientific data from scientific publications and regulatory dossiers of approved products and provide insights and summary documents to internal key stakeholders as part of decision-making process
* Prepare and review documents for regulatory submissions, in particular module 2 clinical and non-clinical summaries
* Provide project management support to ensure regulatory documents are prepared in line with agreed strategic goals and timelines, and in compliance with applicable regulatory requirements
* Prepare gap analyses and relevant sections of product development plans, and support the Head of Regulatory Affairs in defining regulatory strategies
* Engage in regulatory authority meetings by preparing meeting requests and meeting package and attending teleconferences whenever required by global health authorities
* Attend team meetings and engage with internal and external stakeholders providing regulatory support to the product development team
* Maintain knowledge of relevant guidance (in particular US-FDA focused) and provide advice on key requirements for development activities