Position seek: Chargé(e) d’affaires Regulatory Affairs - conformable in French speaking
About the company
Mpharma is a small pharmaceutical company specialised on niche products. We provide pharmaceutical products asked by clinicians about patients suffering from relatively rare indications/diseases or specific diagnosis, staging, prognosis and therapeutic monitoring. We are present with 3 niche products with marketing approvals in the radio-pharmacy field in Europe (UK, Ireland, France, etc.) and also in Asia, Canada and Middle East territories.
We are looking at opening this position in Birmingham.
Location
Birmingham
Type
contract - part time (start)
Mission
- Understanding, sterile and radio-pharmaceutical products; CMC, national and mutual recognition.
- When needed, filing of marketing authorization dossiers and tracking requests, answers to questions of health authorities and collecting the necessary supplements
- Writing post MA files (renewal and variation) and make deposits to health authorities and monitoring. Maintenance activities to comply with regulations (including variation) Type 1A, Type 1B, Type II, batch specific variations and Renewal applications for a portfolio of MAs into Europe and ROW
- Monitoring of regulatory compliance of the advertising deposit
- Transmission MA text to be applied to packaging materials. Validation of packaging items Tracking changes of text packaging articles imposed by health authorities
- SOPs: writing and manage procedures inherent in the regulatory activity
- Management of databases and file archiving and regulatory information
- Audit of manufacturers (Europe)
Candidate’s profile
smiling and always positive for various other duties in connection with export sales support & customer service. Conformable in French specking is welcome.
The position part time contact could me confirmed into permanent
Regulatory Affairs in Birmingham employer: mpharma
mpharma is an exceptional employer located in Birmingham, offering a dynamic work environment that fosters professional growth and development. As a part-time Regulatory Affairs Specialist, you will benefit from flexible working hours while engaging in meaningful tasks that directly impact healthcare compliance across Europe and beyond. The company promotes a collaborative culture, ensuring that employees are supported in their roles and have opportunities to advance their careers within the organisation.
