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.
- 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
- Work well independently.