Regulatory Affairs Specialist

Recordati

Milan, Italy

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 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

The candidate will be responsible for the preparation, review and submission of regulatory documentation to Health Authorities, as well as for the management of regulatory data and documentation within relevant electronic systems, in support of:

New Marketing Authorisation Applications Line-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

Based on the products assigned, the Regulatory Affairs Specialist will also:

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 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)