Sr. Spclst, Regulatory Affairs
Pubblicato il 20-09-2026 - Altro in Italia
Job Description
Responsible for execution of local RA processes and activities in alignment withRA systems and their associated Quality Management System, followingdepartment SOPs, company Policies and Procedures and country legislation.
Assists in development of product registration plans & strategies and working cross-functionally to review & communicate the registration strategy with management oversight.
Assists in timely preparation, submission of new Marketing Authorization Applications to local Health Authorities, maintenance of authorized products through timely submission of post-market regulatory dossiers, including but not limited to variations, renewal applications and supplemental marketing authorizations in accordance with local regulations and global standards.
Files, stores and archives safety-related and regulatory data and documentation in accordance with department and company policies and local requirements.
Acts in full compliance with global and local SOPs and reports any deviations or compliance concerns immediately and assists in preparing necessary corrective actions and preventative actions (CAPAs) locally for non-compliance issues.
Supports local RA audits and inspections including readiness activities and supports other audits/inspections including the development of CAPAs in response to findings/observations.
Participates in and supports audits of contractual partners/vendors as necessary.
May be trained and assigned responsibility to conduct qualification and ongoing audits of vendors and perform due diligence activities for local country licensing agreements.
Assists in developing local procedures (in compliance with regional and global standards) for the department, to ensure quality of the RA data and evaluates processes for potential improvement in efficiency and effectiveness.
Proactively identifies procedural gaps and challenges and implements solutions in collaboration with all affected stakeholders.
Supports training of the loca