Regulatory Affairs Specialist
Pubblicato il 02-08-2026 - Recordati in Italia
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Regulatory Affairs Specialist
ID: 2550
Date of Posting: Jul 5, 2026
Business Area: Regulatory Affairs
Job Type: Direct Employee
On site / Remote / Hybrid: Hybrid
Hub Office:
Milano, IT
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Territory:
Full-Time or Part-Time: Tempo pieno
Seniority: Mid-senior
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At Recordati, we are united by a clear purpose: unlocking the full potential of life. With a century of history behind us, we are building the next chapter of our journey, continuing to grow while keeping patients at the centre of all we do.
What drives us is a shared belief that health, and the opportunity to live life to the full, should be within reach for everyone. This brings energy to our work, shaping how we support each other and show up every day. Our values – Better Together, Never Settle and Always Deliver – reflect this mindset, helping us to keep improving and make a meaningful difference.
Above all, these values bring to life our promise to everyone at Recordati, you can unlock your full potential. We know that people thrive when they can be themselves, are trusted and supported, and are given the opportunity to grow and make a meaningful contribution.
Are you ready to unlock your full potential?
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)
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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At Recordati we believe in people! Inspired by our purpose - unlocking the full potential of life - we are committed to creating a diverse environment and cultivating a culture of inclusion. We strive to continually lead with our values and beliefs, enabling our employees to bring their whole selves to work and develop their potential.
We are proud to be an equal opportunity employer. We recruit, develop and reward without regard to, amongst others, gender, sexual orientation, gender identity or expression, national origin, age, physical or mental ability, race, ethnicity, political or religious belief.
If you are looking to join a company where you can try new things, speak openly, and be bold, we invite you to apply today.
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