REGULATORY AFFAIRS MANAGER

Our client is Otsuka, a holistic healthcare company contributing to people's health worldwide.
Otsuka’s pharmaceutical business develops and markets products for the diagnosis and treatment of disease in the following areas: neuroscience, nephrology, haemato-oncology, endocrinology, cardiovascular, renal, ophthalmology and infectious disease.
Since the beginning, 100 years ago, the Otsuka family has sought to travel down the paths of discovery where others are less likely to tread.
Otsuka expanded its pharmaceutical business into Europe in 1974; Otsuka Pharmaceutical Europe Ltd. (OPEL) was established in the U.K. in 1997 as Otsuka’s European regional office, and across Europe we now employ over 500 people. Core functions of sales and marketing, medical and access are present in our affiliate offices across Europe and are supported by OPEL. For other European countries, Otsuka products are managed through a number of partnerships and distributors, ensuring wide European coverage.

For the Italian affiliate (based in Milan) we are looking for a
Regulatory Affairs Manager
Description of role
The Regulatory Manager is responsible for the coordination and control of regulatory activities in order to ensure compliance with the National/local Regulations. He/she ensures a regular updating on the new National/Local regulatory aspects and maintains relations with the competent authorities and Head Office for everything concerning regulatory aspects.
Works in collaboration with the different departments and reports to the Market Access & Regulatory Director

Key Responsibilities
Coordination and control of regulatory activities:

Check and approve the promotional/disease awareness materials proposed by Marketing/ Medical/Access functions.
Check and approve the artworks (PIL, Primary and secondary packaging) sent by Head Office.
QC Linguistic review of PI sent by Head Office
Ensures compliance, from the regulatory point of view, of the requirements set by national and regional regulations.
Manage the appointment of ISF at regional/local level
Communication about ISF activities to regional/national authorities
Management of database maintenance such as CODIFA, Farmastampati / Farmadati, Unifarm etc.
Monitoring of Agencies website (AIFA, EMA…)
Ensure constant updating regarding new national regulations in the regulatory field.
Interact with the competent authorities for all regulatory aspects
Strategic support to product teams on regulatory aspects
Contact point for regulatory aspects with the Head Office.

Professional Expertise

Scientific University Degree
2+ years of experience in the role

Leadership & Behavioural Competencies

Communication skills
Building and maintaining relationship
Negotiations skills
Positive attitude, flexibility and a proactive approach
Cross functional awareness
Resilience
Strive for excellence
Operate in compliance

Functional & Technical Competencies

Regulatory competencies (Local legislation requirements and Scientific Background)
Solid understanding of relevant therapeutic areas and marketplace
Project Management
English (written and oral)

Business unit	Regolatorio
Sedi	Italia/Lombardia/Milano

REGULATORY AFFAIRS MANAGER

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