Job Title: Regulatory Affairs Consultant CMC - Combination Products
Location: Homebased in UK or EU
Salary: 45,000 - 65,000 plus package
Working with one of the worlds most established Pharma's, this role will play a pivotal role in the development of an innovative combination product portfolio.
In this role you will be responsible for supporting the CMC regulatory activities relating to development, registration and manufacturing of devices (standalone and in all types of drug-device combinations).
- Responsible for the global CMC regulatory activities associated with devices for assigned projects and respond readily to changing events and priorities.
- Responsible for CMC strategy development (with managerial support) and creation of CMC submission documents for devices from early phase clinical submissions (IND/IMPD) through to marketing applications (NDA/BLA/MAA) and commercial lifecycle management activities in accordance with the applicable regulatory & scientific standards.
- Works in cross-functional matrix project teams, which include colleagues from regulatory, development, quality and manufacturing ensuring adequate interaction and partnership in order to define proper regulatory CMC filing strategy for devices.
- Engages in CMC Subject Matter Expert activities internally (for increased compliance,harmonisationand efficiency) and potentiallyexternal advocacy and shaping the regulatory environment).
- Device regulatory affairs or device (standalone and in all types of drug-device combinations) development and manufacturing experience with direct involvement in regulatory submission preparation for devices.
- Sound knowledge of device development, manufacturing processes and supply chain.
- Knowledge of worldwide CMC regulatory requirements for devices and successful track record of delivering dossiers that comply with these
- Development experience ideally including previous roles within product development (preferred)
To be considered please respond with an updated version of your CV and I will be in touch to discuss this further - firstname.lastname@example.org
- Agency: Cpl Life Sciences
- Reference: JO-2206-494898
Website: Cpl Life Sciences
- Posted: 15th June 2022
- Expires: 13th July 2022