Regulatory AffaiRegulatory Affairs Associate - Fix-term contractrs Associate - Temporary

Recordati; Milano; In loco; EUR 32.400 - 39.600; Tempo pieno

Descrizione del lavoro

Recordati is seeking a Regulatory Affairs Associate for a fixed-term contract in Milan. This entry-level position is focused on managing regulatory activities for SPC medicinal products in the EU and non-EU regions.

The ideal candidate will hold a scientific degree and preferably a master's in Regulatory Affairs, with at least 6 months of experience in a multinational pharmaceutical firm or regulatory consulting. A gross annual salary starting from 36,000 € is offered.

Competenze

• Minimum 6 months to 1 year experience in Regulatory Affairs.
• In-depth knowledge of pharmaceutical legislation for medicinal products.
• Ability to manage data using electronic systems.

Mansioni

• Manage new Marketing Authorization Applications.
• Collaborate on regulatory submissions timelines.
• Maintain relations with Regulatory Authorities.

Conoscenze

Experience in Regulatory Affairs

Knowledge of pharmaceutical legislation

Data management systems

Strong communication skills

Team-player attitude

Formazione

Scientific Degree

Master in Regulatory Affairs

Strumenti

Electronic systems (RIMS, DMS, eCTD)

Descrizione del lavoro

RegulatoryAffaiRegulatoryAffairs Associate - Fix-term contractrs Associate - Temporary

ID: 2687

Date of Posting: Jun 25, 2026

Business Area: Regulatory Affairs

Job Type: Direct Employee

Territory:

Full-Time or Part-Time: Full Time

Seniority: Entry level

Job Purpose

We are looking for a Regulatory Affairs Associate - Fixed-term contract 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

• 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)

Based on the products assigned, the Regulatory Affairs Associate 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 regulatory compliance
• Provide regulatory assessment for new business opportunities

Required Education

• Scientific Degree
• Master in Regulatory Affairs (preferred)

Required Skills and Experience

• At least 6 months/1 year of experience in Regulatory Affairs within multinational pharmaceutical firms (ideally at parent companies) or international regulatory consulting companies
• In-depth knowledge of pharmaceutical legislation for medicinal products for human use
• 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

Salary

Gross Annual Salary starting from: 36,000 €

Please note: The salary indicated in this posting complies with local pay transparency regulations for Italian employment contracts. Final offers will be tailored to the successful candidate's experience, professional expertise, and interview journey, while ensuring internal equity. At Recordati, we are committed to a comprehensive, fair, and competitive remuneration system; a full overview of your total rewards package will be shared and discussed with you during the recruiting process.

Equal Opportunity Statement

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.