Senior Expert, Regulatory Operations-Fixed-Term Contract

Dompé is an Biopharmaceutical company driven by innovation and research, with headquarters in Milan and operations across Europe and the United States. The company focuses on developing and delivering therapeutic solutions in areas of high unmet medical need, combining scientific excellence, digital innovation, and a strong commitment to improving patients’ lives.

For our office in
**Tirana**
we are looking for an
**Regulatory Operations Senior Expert Fixed-Term Contract**
. The Regulatory Operations Senior Expert assist in managing the lifecycle management (LCM) activities by archiving, creating, and maintaining specific categories of regulatory documentation and data. This role involves working closely with the Regulatory Strategy Team and other internal departments to meet assigned deliverables. The function includes providing submission publishing/verification and regulatory compliance support.

**Responsibilities**
:

- Support the preparation of the submission dossier, for the assigned products and countries, coordinating the assembly and following all the steps until approval;
- Works closely and partners with the Operation Lead for the lifecycle management procedures (i.e IND, CTA, MAA, renewals of registrations, extensions, variations);
- Support the management of Labelling and Artworks for the assigned products and countries;
- Support the Line Manager in the interactions with other company functions;
- Be constantly updated on the regulatory laws/guidelines and verify/apply the correct legislation in the managed processes;
- Contributor-level experience with RIM.
- Ensure the update of the RIM system for the assigned submissions;
- Ensure the storage of all documents, according to the defined flow;
- Participates in pharmacovigilance activities within own competence;
- Perform the "regulatory alerting" concerning products and countries.

**Qualifications**
:

- Bachelor’s degree: Degree in any field of science;

**Required Skills**
:

- **Italian and English (fluently);**

**Preferred Skills**
:

- Knowledge of basic IT applications and excellent knowledge of Office (Word, Excel, Power Point);
- Knowledge of Regulatory Information Management system;