Regulatory Affairs Associate

Competitive Salary
Flexible Working

About Our Client

Our sole aim is to deliver best-in-class drug treatments and support to the under-served rare disease patient community.
We focus on rare metabolic, immunological and neurological genetic conditions. Our patients typically require life-long treatment with life-saving medicine. Our approach is to utilize the latest cutting-edge pharmaceutical technologies to deliver the required medicine, with the minimum impact on daily routines.

Job Description

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

The Successful Applicant

Required Knowledge
* A high scientific calibre with a life science focused BSc.
* Higher degree (e.g., a life science focused MSc or PhD) would be preferrable
* At least 2 years practical/technical experience in pharmaceutical product development, working within SME biotech/small pharma or in academic environment preferably in Regulatory Affairs in pre submission and post approval management of licenses.
* A good understanding of the regulatory regulations in EU and USARequired skills
* Excellent written and oral communication.
* A strong ability to quickly assimilate, interpret and summarise scientific information Ability to work in a proactive and autonomous manner, as well as being part of a team.
* Good project management skills with a high level of attention to detail.
* Ability to create strong working relationships across the organisation and with external partners.
* Self-motivated, enthusiastic and hard-working.
* Strong analytical, organisational and problem-solving skills.