Regulatory Affairs Expert

4 settimane fa

Abano Terme PD, Italia Fidia Farmaceutici A tempo pieno 32.000 € - 38.000 €

Founded in 1946, Fidia is a fully integrated Italian multinational company, with R&D, Manufacturing, Marketing and Sales capabilities headquartered in Abano Terme. Fidia is prioritizing its R&D efforts in areas with the greatest scientific and commercial promise, such as Joint Care, Skin Care, Aesthetic Care, Eye Care and Regenerative Care.

We are recruiting a

Regulatory Affairs Expert (Medicinal Products)

Being part of the Regulatory Affairs Team, the candidate will support the team in all the activities needed for the lifecycle of the medicinal products.

Main Responsibilities:

Supporting the preparation of the regulatory package, responses to HAs requests, submission of the package, follow-up of the pre and post-approval activities of all the regulatory practices (including MAA, VA, MA transfers, MA renewal) of the MAs of the medicinal products.

Management of the changes to the product information and relevant artworks, collaboration with the Pharmacovigilance Department and Scientific Service to guarantee the correct management of the safety variations.

Revision and submission to the Italian HAs of the medicinal product promotional materials for HCPs and public.

Contacts with subsidiaries/distributors as well as other Fidia HQ functions to support the team in the coordination of all regulatory practices.

Requirements:

Degree in Life Science disciplines, preferably in Pharmacy/CTF/Biological Sciences/Chemistry. A specialisation in Regulatory Affairs is a plus.

At least 2 years' experience in the regulatory field with a focus on medicinal products or API, preferably in companies with a manufacturing site.

Knowledge of medicines legislation, GMP and reference guidelines.

Experience of national registrations, preferably also European (DCP, MRP).

Experience in using the various applications of the AIFA portal.

Excellent experience of the MS Office package.

Good level of English (B1).

Skills of team working, ability and willingness to learn, listening, accuracy and flexibility.

Our offer:

Open ended contract.

“C” grading of Chemical Pharmaceutical National Collective Agreement.

Salary between € 32.000 and € 38.000.

Collective Bonus and company Welfare.

Fidia benefits:

Unlimited access to training and coaching programs aligned with market best practices.

Opportunities for professional development through participation in internal job posting processes.

Pension fund with company integration and health fund.

Merit review and referral programs.

Company canteen, staff discounts, and access to the flu vaccination campaign.

Fidia Farmaceutici promotes parity and inclusion in all its actions.

All people from the status of candidate to that of employee and throughout the duration of their employment relationship are entitled to the same opportunities and protections regardless of gender identity, sexual orientation, ethnicity, migration background, religion, nationality, age.

All company procedures are therefore drafted in compliance with the principles expressed in the previous point; any divergences should be promptly brought to the attention of the People & Culture Department.

#J-18808-Ljbffr

  • Regulatory Affairs Expert

    4 settimane fa

    Abano Terme, Italia Fidia Farmaceutici A tempo pieno

    Founded in 1946, Fidia is a fully integrated Italian multinational company, with R&D, Manufacturing, Marketing and Sales capabilities headquartered in Abano Terme. Fidia is prioritizing its R&D efforts in areas with the greatest scientific and commercial promise, such as Joint Care, Skin Care, Aesthetic Care, Eye Care and Regenerative Care. We are...

  • Regulatory Affairs Expert

    4 settimane fa

    Abano Terme, Italia Fidia Farmaceutici A tempo pieno

    Founded in 1946, Fidia is a fully integrated Italian multinational company, with RD, Manufacturing, Marketing and Sales capabilities headquartered in Abano Terme.Fidia is prioritizing its RD efforts in areas with the greatest scientific and commercial promise, such as Joint Care, Skin Care, Aesthetic Care, Eye Care and Regenerative Care.We are recruiting a...

  • Regulatory Affairs Expert

    5 mesi fa

    Abano Terme, Italia Fidia Farmaceutici A tempo pieno

    Founded in 1946 Fidia is a fully integrated Italian multinational company, with R&D, Manufacturing, Marketing and Sales capabilities headquartered in Abano Terme. Fidia is prioritizing its R&D efforts in areas with the greatest scientific and commercial promise, such as Joint Care, Skin Care, Aesthetic Care, Eye Care and Regenerative Care. We are recruiting...

  • Regulatory Affairs Manager

    3 settimane fa

    Abano Terme, Veneto, Italia Fidia Farmaceutici Spa A tempo pieno

    Fidia Farmaceutici Spa is seeking a highly skilled Regulatory Affairs Specialist to join its team. As a key member of the Regulatory Affairs Team, the successful candidate will be responsible for managing the lifecycle of medicinal products, preparing regulatory documents, and maintaining product dossiers.The ideal candidate will have a Bachelor's degree in...

  • Regulatory Affairs Support

    6 mesi fa

    Abano Terme, Italia Fidia Farmaceutici A tempo pieno

    Siamo alla ricerca di una risorsa brillante da inserire all'interno della Direzione Regulatory Affairs in un contesto di respiro internazionale. La risorsa di occuperà di supportare nelle seguenti attività: - gestione archivio cartaceo ed elettronico - gestione spedizioni - gestione budget di reparto - supporto attività amministrative regolatorie Si...

  • Regulatory Affairs Specialist

    5 mesi fa

    Abano Terme, Italia Fidia Farmaceutici A tempo pieno

    Founded in 1946 Fidia is a fully integrated Italian multinational company, with R&D, Manufacturing, Marketing and Sales capabilities headquartered in Abano Terme. Fidia is prioritizing its R&D efforts in areas with the greatest scientific and commercial promise, such as Joint Care, Skin Care, Aesthetic Care, Eye Care and Regenerative Care. We are recruiting...

  • Corporate Medical Affairs Senior Manager

    1 mese fa

    Abano Terme (PD), Italia Fidia Farmaceutici A tempo pieno 75.000 € - 93.000 €

    Founded in 1946, Fidia is a fully integrated Italian multinational company, with R&D, Manufacturing, Marketing, and Sales capabilities headquartered in Abano Terme. Fidia is prioritizing its R&D efforts in areas with the greatest scientific and commercial promise, such as Joint Care, Eye Care, Skin Care, Aesthetic Care, Regenerative Care, Primary Care, and...

  • QA Expert

    1 mese fa

    Abano Terme (PD), Italia Fidia Farmaceutici A tempo pieno 32.000 € - 33.000 €

    Founded in 1946, Fidia is a fully integrated Italian multinational company, with R&D, Manufacturing, Marketing and Sales capabilities headquartered in Abano Terme. Fidia is prioritizing its R&D efforts in areas with the greatest scientific and commercial promise, such as Joint Care, Eye Care, Skin Care, Aesthetic Care, Regenerative Care, Primary Care, and...

  • Corporate Medical Affairs Senior Manager

    1 mese fa

    Abano Terme, Italia Fidia Farmaceutici A tempo pieno

    Founded in 1946, Fidia is a fully integrated Italian multinational company, with RD, Manufacturing, Marketing, and Sales capabilities headquartered in Abano Terme.Fidia is prioritizing its RD efforts in areas with the greatest scientific and commercial promise, such as Joint Care, Eye Care, Skin Care, Aesthetic Care, Regenerative Care, Primary Care, and...

  • Corporate Medical Affairs Senior Manager

    1 mese fa

    Abano Terme, Italia Fidia Farmaceutici A tempo pieno

    Founded in 1946, Fidia is a fully integrated Italian multinational company, with R&D, Manufacturing, Marketing, and Sales capabilities headquartered in Abano Terme. Fidia is prioritizing its R&D efforts in areas with the greatest scientific and commercial promise, such as Joint Care, Eye Care, Skin Care, Aesthetic Care, Regenerative Care, Primary Care, and...

  • Corporate Medical Affairs Senior Manager

    1 mese fa

    Abano Terme, Italia Fidia Farmaceutici A tempo pieno

    Founded in 1946, Fidia is a fully integrated Italian multinational company, with R&D, Manufacturing, Marketing, and Sales capabilities headquartered in Abano Terme. Fidia is prioritizing its R&D efforts in areas with the greatest scientific and commercial promise, such as Joint Care, Eye Care, Skin Care, Aesthetic Care, Regenerative Care, Primary Care, and...

  • Global Corporate Digital Communication Specialist

    5 mesi fa

    Abano Terme, Italia Fidia Farmaceutici Spa A tempo pieno

    Founded in 1946 Fidia is a fully integrated Italian multinational company, with R&D, Manufacturing, Marketing and Sales capabilities headquartered in Abano Terme. Fidia is prioritizing its R&D efforts in areas with the greatest scientific and commercial promise, such as Joint Care, Skin Care, Aesthetic Care, Eye Care and Regenerative Care.We are recruiting...

  • Stage Junior Regulatory Affairs Assistant | Bologna

    4 settimane fa

    Castel San Pietro Terme, Italia Intertek A tempo pieno

    Our PurposeBringing quality, safety, and sustainability to lifeUnisciti al nostro team ed entra a far parte di un network globale impegnato per la qualità, la sicurezza e la sostenibilità!Intertek, principale realtà multinazionale di servizi ATIC (Assurance, Testing, Inspection and Certification) ricerca un/una stagista Junior Regulatory Affairs Assistant...

  • Qa Expert

    1 mese fa

    Abano Terme, Italia Fidia Farmaceutici A tempo pieno

    Founded in 1946, Fidia is a fully integrated Italian multinational company, with R&D, Manufacturing, Marketing and Sales capabilities headquartered in Abano Terme. Fidia is prioritizing its R&D efforts in areas with the greatest scientific and commercial promise, such as Joint Care, Eye Care, Skin Care, Aesthetic Care, Regenerative Care, Primary Care, and...

  • Qa Expert

    3 settimane fa

    Abano Terme, Italia Fidia Farmaceutici A tempo pieno

    Founded in 1946, Fidia is a fully integrated Italian multinational company, with R&D, Manufacturing, Marketing and Sales capabilities headquartered in Abano Terme.Fidia is prioritizing its R&D efforts in areas with the greatest scientific and commercial promise, such as Joint Care, Eye Care, Skin Care, Aesthetic Care, Regenerative Care, Primary Care, and...

  • Qa Expert

    1 mese fa

    Abano Terme, Italia Fidia Farmaceutici A tempo pieno

    Founded in 1946, Fidia is a fully integrated Italian multinational company, with RD, Manufacturing, Marketing and Sales capabilities headquartered in Abano Terme.Fidia is prioritizing its RD efforts in areas with the greatest scientific and commercial promise, such as Joint Care, Eye Care, Skin Care, Aesthetic Care, Regenerative Care, Primary Care, and...

  • Qa Expert

    1 mese fa

    Abano Terme, Italia Fidia Farmaceutici A tempo pieno

    Founded in 1946, Fidia is a fully integrated Italian multinational company, with R&D, Manufacturing, Marketing and Sales capabilities headquartered in Abano Terme. Fidia is prioritizing its R&D efforts in areas with the greatest scientific and commercial promise, such as Joint Care, Eye Care, Skin Care, Aesthetic Care, Regenerative Care, Primary Care, and...

  • European Packaging Specialist

    1 mese fa

    Cadoneghe (PD), Italia Nestlé SA A tempo pieno

    European Packaging Specialist - Glass & Metal Caps Nestlé Waters, part of Nestlé, is the number one bottled water company worldwide. We are present in most distribution channels with a large portfolio of 51 unique brands including Nestlé Pure Life, our No. 1 bottled water brand, Perrier and San Pellegrino. We’re passionate about creating shared value...

  • European Packaging Specialist

    3 settimane fa

    San Giorgio in Bosco (PD), Italia Nestle Operational Services Worldwide SA A tempo pieno

    Nestlé Waters, part of Nestlé, is the number one bottled water company worldwide. We are present in most distribution channels with a a large portfolio of 51 unique brands including Nestlé Pure Life, our No. 1 bottled water brand, Perrier and San Pellegrino. We’re passionate about creating shared value for society in all kinds of ways: from providing...

  • Business Developer

    1 settimana fa

    Cadoneghe (PD), Italia Mida Solutions, a NUSO Company A tempo pieno

    Mida Solutions, a NUSO company delivers complex cloud communication solutions in real-time through authorized channel partners serving the small to medium business (SMB) and enterprise markets. Our transparent approach presents our channel partners as an ally instead of a competitor. Natively developed real-world business communication tools seamlessly...