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Farmaceutica à Italie

Head Of Regulatory Affairs

Head Of Regulatory Affairs
Alfasigma
Monza
EUR 90 000 - 120 000
Poste urgent
Il y a 2 jours
Je veux recevoir les dernières offres d’emploi de Farmaceutica

AGENTE DI VENDITA CANALE FARMACIA_NORD SARDEGNA

AGENTE DI VENDITA CANALE FARMACIA_NORD SARDEGNA
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Sassari
EUR 30 000 - 50 000
Poste urgent
Il y a 2 jours

Project and Service Agreement Manager - Building Automation and Fire security systems - Milan

Project and Service Agreement Manager - Building Automation and Fire security systems - Milan
Experteer Italy
Cusano Milanino
EUR 35 000 - 55 000
Poste urgent
Il y a 2 jours

83 - Personale di Farmacia

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Belluno
EUR 30 000 - 40 000
Poste urgent
Il y a 2 jours

Chemical Lab Documentation Specialist

Chemical Lab Documentation Specialist
Experteer Italy
Melzo
EUR 35 000
Poste urgent
Il y a 2 jours
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Informatore / Informatrice scientifico / a commerciale | Campania

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Mugnano di Napoli
EUR 30 000 - 45 000
Poste urgent
Il y a 2 jours

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Milano
EUR 30 000 - 40 000
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Milano
EUR 70 000 - 100 000
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Monza
EUR 25 000 - 35 000
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Il y a 2 jours

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Quality Assurance Manager

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Global Pricing Lead
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Firenze
EUR 90 000 - 130 000
Poste urgent
Il y a 2 jours

Construction Planner - Pharma, Life Science & Industrial

Construction Planner - Pharma, Life Science & Industrial
Experteer Italy
Cusano Milanino
EUR 40 000 - 60 000
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IQVIA Italia
Modena
EUR 50 000 - 70 000
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Product Marketing Manager Consumer Health (m/f)

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Experteer Italy
Cusano Milanino
EUR 40 000 - 60 000
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MENARINI Group
Lucca
EUR 50 000 - 80 000
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Pavia
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Milano
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Clinical Research Associate II / Sr. CRA, Italy

Clinical Research Associate II / Sr. CRA, Italy
Rho
Italie
À distance
EUR 40 000 - 65 000
Poste urgent
Il y a 2 jours

Clinical Research Associate II

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ICON
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Technical Business Manager - 1 year fixed term

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Postes : Azienda Farmaceutica

Head Of Regulatory Affairs

Faites partie des premiers candidats.
Alfasigma
Monza
EUR 90 000 - 120 000
Faites partie des premiers candidats.
Il y a 2 jours
Description du poste

Philogen S.P.A. would like to hire a highly motivated and qualified Head of Regulatory Affairs to lead our regulatory function and ensure compliance with global regulatory requirements. This is a key leadership role responsible for developing and executing regulatory strategies that support the company’s product development and commercialization goals.Position SummaryWe are seeking a highly experienced and strategic Head of Regulatory Affairs to lead our global regulatory efforts, with a particular focus on clinical development programs. The successful candidate will bring deep expertise in EMA and FDA regulatory pathways, scientific advice procedures, and eCTD submissions. This role is pivotal in shaping and executing our regulatory strategy across all stages of product development, from early clinical trials to market authorization.Key ResponsibilitiesDefine and implement global regulatory strategies to support clinical development and product registration.Lead the preparation and submission of regulatory documents, including INDs, CTAs, MAAs, NDAs, amendments, and responses to health authority questions.Manage and coordinate all aspects of EMA and FDA interactions, including scientific advice, pre-IND/IMPD meetings, and advisory committee preparation.Ensure timely and compliant preparation of dossiers in eCTD format.Maintain up-to-date knowledge of global regulatory requirements, trends, and best practices.Represent the company in direct communications and meetings with regulatory agencies.Collaborate closely with cross-functional teams including Project Management, Medical Team, Pharmaco Vigilance, CMC, and Quality Assurance.QualificationsAdvanced degree (PhD, PharmD, MD, or MSc) in a life sciences discipline.Minimum 10 years of experience in Regulatory Affairs within the pharmaceutical or biotech industry.Proven track record of successful interactions with both EMA and FDA across multiple phases of development.Strong knowledge of eCTD format, GCP, ICH guidelines, and global clinical trial regulations.Experience leading regulatory strategy for clinical-stage programs is essential.Excellent leadership, communication, and project management skills.Strategic mindset with the ability to anticipate regulatory trends and proactively manage risks.Preferred AttributesExperience in oncology or immunology drug development.Prior involvement in health authority advisory meetings and global regulatory submissions from early-phase to post-marketing.Familiarity with orphan drug designation, fast track, and breakthrough therapy programs is a plus.We offerA contract and salary proportional to the experience (seniority) of the successful candidate.Job locationMilano/Siena - ItalyWe invite interested candidates to submit their applications expressly authorizing the processing of personal data in accordance with Legislative Decree 196/2003. Our recruitment adheres to the provisions of Legislative Decree 198/2006, and we welcome applications from candidates of any gender orientation or expression, sexual orientation, age, ethnicity, or religious belief.

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Mission:Develop and execute regulatory strategies and plans to ensure compliance with applicable laws, regulations, and standards. Stay updated on changes in regulatory requirements and translate them into actionable steps for the organization. Regulatory affairs Manager is...

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We are seeking a highly motivated and detail-oriented Global Regulatory Affairs Operations Specialist to join our Content Management team. In this role, the hired person will be instrumental in supporting the Content Management Manager and ensuring the successful...

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