Job Purpose
We are looking for a Regulatory Affairs Specialist to join the International Corporate Regulatory Affairs team, responsible for managing regulatory activities for SPC medicinal products for human use.
Responsibilities
Responsibilities include obtaining and maintaining marketing authorizations in the European Union (through CP/MRP/DCP) as well as supporting regulatory activities in various non-EU regions, including Africa, Asia Pacific, CENAM, CSI, LATAM, MENA.
Key Responsibilities
New Marketing Authorisation ApplicationsLine-extension,
Renewal of Marketing Authorizations
Variations Type IA, IB, II (including grouping and worksharing procedures) or equivalent procedures in accordance with national legislation
Marketing Authorization transfers
Notification of start and end of marketing
Requests for Sunset Clause exemptions
Review and approval of printed materials (artworks and mock-ups)
Request for Notified Body Opinions
Define regulatory activity plans and related costs
Collaborate with cross-functional teams to define and manage timelines for the preparation of regulatory submissions
Contribute to the management of core dossiers, including gap analysis activities, to support registrations across multiple international markets, in collaboration with relevant departments
Coordinate with the group's affiliates, licensees and consultancy companies




Maintain relations with the Regulatory Authorities
Monitor the legislation in force and assure the regulatory compliance
Provide regulatory assessment for new business opportunities
Required Education
Scientific Degree
Master in Regulatory Affairs (preferred)
Required Skills and Experience
More than 5 years of experience in Regulatory Affairs within multinational pharmaceutical frims (ideally at "parent companies") or international regulatory consulting companies Experience with the EU Centralised xysqume and Decentralised Procedures Background in OTC product development and lifecycle management High level of autonomy in managing assigned activities
Technical Competencies
In-depth knowledge of pharmaceutical legislation for medicinal products for human use and medical devices Experience in the use of electronic systems for the management of data and regulatory documents (RIMS, DMS, eCTD platform)
Required Behaviours and Competencies
Positive and proactive mindset, with a solution?oriented approach
Strong communication and collaborative skills, team?player attitude
Effective time management and organisational skills
Flexibility and adaptability in a dynamic environment
Strong work ethic
Required Languages
Fluent in English
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📌 Regulatory Affairs Specialist (Spoleto)
🏢 EUSA Pharma
📍 Spoleto