about 2 years ago
Job title: (Senior) Regulator Affairs Manager
A Generics business in Central London are seeking a (Senior) Regulatory Affairs Manager to work on MAAs for a range of new products. This role will b responsible for the registration and delivery of several new product pipelines from initial identification to commercial launch.
- Management of new product pipeline inline with internal strategy and business objectives
- Preparation of submission strategies and dossier management
- Submission of regulatory applications for new pipeline products, including inlicensing, product developments and registering existing products into new markets.
- Direct communication with relevant healthcare authorities to ensure compliance
- Experience within submissions of new products
- Experience in submissions of National and European MAA
- Significant understanding and experience preparing Common Technical Dossiers
- BSc Life Science degree as a minimum
- Broad knowledge and awareness of the European regulatory guidelines and legislation
Salary and benefits:
A competitive salary, annual bonus, pension and private healthcare are on offer
To apply for this position or hear further details then please contact Matt Thomas via email@example.com