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

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

Descrizione del lavoro

Recordati is seeking a Regulatory Affairs Associate on a fixed-term contract to join the International Corporate Regulatory Affairs team in Italy. You will manage regulatory activities for SPC medicinal products for human use, including EU marketing authorisations and non-EU submissions.

Responsibilities include preparing and submitting regulatory documentation, coordinating with cross-functional teams, maintaining core dossiers, and monitoring legislation to ensure compliance.

Competenze

• At least 6 months to 1 year of experience in Regulatory Affairs in multinational pharma.
• In-depth knowledge of pharmaceutical legislation for human use.
• Experience with electronic systems for regulatory documents management.

Mansioni

• Prepare, review and submit regulatory documentation to Health Authorities.
• Manage regulatory data in electronic systems and support submissions.
• Define regulatory activity plans and timelines with cross-functional teams.
• Coordinate with affiliates, licensees and consultants on regulatory activities.
• Monitor legislation and ensure regulatory compliance across markets.
• Provide regulatory assessment for new business opportunities.

Conoscenze

Regulatory knowledge

Documentation management

Communication skills

Time management

Formazione

Scientific Degree

Master in Regulatory Affairs (preferred)

Strumenti

RIMS

DMS

eCTD platform

Descrizione del lavoro

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 authorisations 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 Authorisations
• 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 the 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.

Technical Competencies

• 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

Required Languages

Fluent in English

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.

EEO Statement

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.