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

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.

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