Regulatory Affairs Manager

March 29

Recordati

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Since 1926, working to improve the lives of our patients and their families

Drug development • marketing • distribution

1001 - 5000

💰 Funding Round on 2018-11

Description

• In coordination with area managers and HQ Regulatory, defines international regulatory strategies • Timely coordination of regulatory activities between Recordati internal stakeholders and third parties in the countries to support SALINT business • Act as Regulatory’s point of contact for the area managers • In alignment with HQ regulatory team, act as point of contact with local partners to define submission strategies and required documentation • Cooperate with cross-functional teams to determine and manage timelines for the preparation of regulatory filings • Contributes to business cases (and later contract editing) related to SALINT’s corporate products, in particular by agreeing on the action plan with HQ regulatory team • Cooperates to M&A and in-licensing assessments for SALINT’s corporate products • Collaborate with HQ regulatory team on the lifecycle management of Marketing Authorizations related to SALINT • Ensure maintenance and update of the regulatory status of registered products (e.g. MAH status, MAT status related to SALINT activities…) using defined archiving systems • Manage appropriate archiving of official approval documents and correspondence from the Regulatory Authorities for SALINT products/partnerships • Responsible for creating and maintaining a yearly roadmap to ensure prioritization of regulatory activities for International. • Provide all needed information concerning budget and forecast for SALINT products and activities • Concerning SALINT corporate products, provide on time information on activities and planning

Requirements

• Knowledge, at least in a general way, of pharmaceutical regulations applicable in Europe, Latin America, Asia, Pacific, Middle east • Knowledge of the CTD dossier and product information, and related guidelines • Very strong command of English • Project management • Strong organisation skills • Communication skills and in particular ability to work with different cultures • Management by influence, i.e. ability to promote SALINT reg. projects within the organisation • Academic qualifications: relevant degree in a subject such as chemistry, biochemistry, biotechnology, pharmacy, medicinal chemistry, biomedical science, life or applied science (regulatory certifications would be a plus) • Work experience: experience in international regulatory affairs is mandatory • Occasional travel to Global Headquarters in Milan • Communication with third parties in different time zones

Benefits

• Role can be remote with occasional days onsite at Recordati Ireland office in Cork. For this reason, candidates should be living in Ireland.