ph3RegulatoryAffaiRegulatoryAffairs Associate - Fix-term contractrs Associate - Temporary /h3 pID: **** /p pDate of Posting: Jun 25, **** /p pBusiness Area: Regulatory Affairs /p pJob Type: Direct Employee /p pTerritory: /p pFull-Time or Tempo parziale: Full Time /p pSeniority: Entry level /p h3Job Purpose /h3 pWe 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.
/p h3Key Responsibilities /h3 ul liNew Marketing Authorisation Applications /li liLine extension /li liRenewal of Marketing Authorizations /li liVariations Type IA, IB, II (including grouping and worksharing procedures) or equivalent procedures in accordance with national legislation /li liMarketing Authorization transfers /li liNotification of start and end of marketing /li liRequests for Sunset Clause exemptions /li liReview and approval of printed materials (artworks and mock-ups) /li /ul pBased on the products assigned, the Regulatory Affairs Associate will also: /p ul liDefine regulatory activity plans and related costs /li liCollaborate with cross-functional teams to define and manage timelines for the preparation of regulatory submissions /li liContribute to the management of core dossiers, including gap analysis activities, to support registrations across multiple international markets, in collaboration with relevant departments /li liCoordinate with the group's affiliates,



licensees and consultancy companies /li liMaintain relations with the Regulatory Authorities /li liMonitor the legislation in force and assure regulatory compliance /li liProvide regulatory assessment for new business opportunities /li /ul h3Required Education /h3 ul liScientific Degree /li liMaster in Regulatory Affairs (preferred) /li /ul h3Required Skills and Experience /h3 ul liAt least 6 months/1 year of experience in Regulatory Affairs within multinational pharmaceutical firms (ideally at parent companies) or international regulatory consulting companies /li liIn-depth knowledge of pharmaceutical legislation for medicinal products for human use /li liExperience in the use of electronic systems for the management of data and regulatory documents (RIMS, DMS, eCTD platform) /li /ul h3Required Behaviours and Competencies /h3 ul liPositive and proactive mindset, with a solution?oriented approach /li liStrong communication and collaborative skills, team?player attitude /li liEffective time management and organisational skills /li liFlexibility and adaptability in a dynamic environment /li /ul h3Salary /h3 pGross Annual Salary starting from: 36,000 € /p pPlease 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.
/p h3Equal Opportunity Statement /h3 pAt 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.
/p pWe 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.
/p /p #J-*****-Ljbffr

📌 Regulatory Affairegulatory Affairs Associate - Fix-Term Contractrs Associate - Temporary (Milano)
🏢 Recordati
📍 Milano