Regulatory Affairs Manager / Senior Manager
- Experience Level
Regulatory Affairs Manager or Senior Manager
My client, a full-service clinical contract research organization (CRO) is looking to to expand their Regulatory Affairs team with the addition of a Regulatory Affairs Manager. They provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries.
As the new Senior Regulatory Affairs Manager, you will provide regulatory expertise, leading all aspects of regulatory for drug-device combination product development from early stage clinical through to commercialisation.
As part of the remit you will also:
- Develop and review of regulatory submission documents for Interaction with EMA, MHRA, and other regulatory agencies;
- Maintain full regulatory applications including Paediatric Investigation Plans (PIPs), Orphan Designations, PRIME and Market Authorisation Applications (MAAs)
- Maintain timelines for full regulatory submissions;
- Provide regulatory advice and guidance to Sponsors and cross-departmentally to ensure compliance with UK and European regulations and requirements;
- Developing scientific and regulatory documents for EU agency meetings;
- Reviewing pertinent regulations and guidance to develop proactive solutions to regulatory issues and challenges.
- Manage and Mentor junior staff members
The ideal candidate will have a degree in a science related field. You will also have a minimum of 5 years' experience within the field of Regulatory Affairs, working with a pharmaceutical company or CRO.
As the new Senior Regulatory Affairs Manager, you will also possess the following characteristics:
- Ability to work strategically within a complex, business critical and high-profile program.
- Significant regulatory affairs experience within MHRA and EU regulations and procedures.
- Strong computer skills, project management skills, and a high attention to detail
Market leading salary and benefits package.