Recordati, established in 1926, is an international pharmaceutical group, listed on the Italian Stock Exchange (Reuters RECI.MI, Bloomberg REC IM, ISIN IT 0003828271), with a total staff of more than 4,300, dedicated to the research, development, manufacturing and marketing of pharmaceuticals. Headquartered in Milan, Italy, Recordati has operations in Europe, Russia and the other C.I.S. countries, Ukraine, Turkey, North Africa, the United States of America, Canada, Mexico, some South American countries, Japan and Australia. An efficient field force of medical representatives promotes a wide range of innovative pharmaceuticals, both proprietary and under license, in several therapeutic areas including a specialized business dedicated to treatments for rare diseases. Recordati is a partner of choice for new product licenses for its territories. Recordati is committed to the research and development of new specialties with a focus on treatments for rare diseases.
Job Summary:
Role can be remote with occasional days onsite at Recordati Ireland office in Cork. For this reason, candidates should be living in Ireland.
• 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
Essential Duties and Responsibilities in the role:
• 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
Essential ‘Technical’ Skills and Abilities:
• 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
Knowledge, Experience and Behavioral Competencies:
• 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
Essential Education and Qualifications:
• 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
Physical Requirements of the Role and work flexibility:
• Occasional travel to Global Headquarters in Milan
• Communication with third parties in different time zones
At Recordati, we believe in equal opportunities and we guarantee that everyone can achieve their potential. We see diversity as a value and will not tolerate any discrimination based on ethnicity, nationality, gender, sexual orientation, disability, age, political or religious belief, or any other personal characteristics. At Recordati, we work hard to create a safe and inclusive work environment, where we all have our rights to physical and psychological integrity respected on a daily basis, as well as our right to freedom of opinion and association. We recognise that we each have a role to play in the success of our business and we implement staff development policies through which everyone’s contribution and achievements can be appropriately rewarded.
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