Oxford Global Resources is looking for a Regulatory Affairs Officer for an important multinational company.
Update the Corporate Product Database (CPD3) with regard to the registration information of human medicinal products, in compliance with the defined requirements and deadlines.
Management of regulatory activities in the System for Launch & Change Implementation (SLCI), in compliance with the local/EU Regulation within the defined deadlines.
Preparation and submission to Health Authorities (HA) of required documentation to support regulatory processes in other countries and export/import of BI products (e.g., Certificates of Pharmaceutical Products, import licenses for psicotropic medicinal products, export certificates for non-registered products).
Preparation and submission to HA of required documentation for the maintenance of existing Manufacturer's and Marketing Holder's Authorisations: Minor administrative changes, major changes (e.g., scope of the authorization, addition of a new production line, facilities changes).
Communications to HA concerning special situations of marketed products: Temporary supply interruptions/potential drug shortages, quality defects/recalls, exceptional marketing/manufacturing authorizations.
Regulatory/Competitive intelligence: Screen reference sources (e.g., HA websites, published databases) to capture and track new/updated relevant information/regulations.
Data reporting for certain medicinal products (e.g., medicinal products listed in the Circular 2/2012)
Review compliance reports related to submission timelines and CPD3 updates.
Preparation and distribution of the agenda and minutes of the Local RA department meetings.
Bachellor in Pharmacy or similar.
At least 2 years of experience in a similar role.
Desirable good level of english.
Standard Full Time or Part Time contract (Possibility of working as freelancer as well)
Attractive salary according to experience in the field.
To Start: ASAP
Duration: 5 months, likely to be extended later or perm.
Location: Sant Cugat, hybrid (2-3 days from home).