Accenian are excited to be working on a new opportunity for a Regulatory Affairs Senior Manager at a speciality pharmaceutical company based in London.
You will coordinate all regulatory activities and provide oversight in regulatory compliance of drug product design. The company has a developing pipeline, including a range of drug-device combination products.
Key Roles & Responsibilities:
Provide regulatory expertise and leadership.
Lead all aspects of regulatory for drug-device combination product development from early stage clinical through to commercialisation.
Interpret regulatory policies and guidance.
Prepare and review regulatory submission documents- marketing authorisation, devices and CTA’s.
Provide assistance and guidance to third-party contractors in developing drug-device combination products.
Interface with global regulatory authorities and notified bodies.
Develops and maintains strong working knowledge of regulatory guidelines.
Build and maintain effective relationships with external stakeholders.
Job Requirements:
Significant regulatory affairs experience within US and EU regulations and procedures.
In-depth working knowledge of FDA regulations on drug-device combination products.
Working knowledge of the EU medical device submission requirements and the EU medical device regulation.
Bachelor’s degree equivalent or higher qualification within Pharmaceutical or relevant life science
Ability to multitask and manage multiple deadlines