Regulatory Affairs Specialist

Fidia Pharma; Abano Terme; In loco; EUR 38.000 - 46.000; Tempo pieno

Descrizione del lavoro

A leading pharmaceutical company based in Abano Terme, Italy, is looking for a Regulatory Affairs Specialist. The role involves managing the lifecycle of medicinal products, preparing regulatory documents, and ensuring compliance with various regulations. Ideal candidates will possess a Bachelor’s degree in Life Sciences and at least 5 years of experience in the regulatory field. The position offers a competitive salary of €38,900 to €45,500 along with various benefits including training programs and a collective bonus.

Servizi

Unlimited access to training and coaching programs

Company pension fund integration

Staff discounts

Competenze

• At least 5 years’ experience in the regulatory field focused on medicinal products.
• Knowledge of medicines legislation, GMP, and reference guidelines.
• Experience managing national procedures and AIFA portal applications.

Mansioni

• Prepare regulatory documents and maintain product dossiers.
• Manage changes to product information and artworks.
• Monitor impact of new regulatory requirements.

Conoscenze

Team working

Critical thinking

Planning

Fluency in English

Formazione

Bachelor’s degree in Life Science disciplines

Strumenti

MS Office

eCTD Manager

Descrizione del lavoro

Regulatory Affairs Specialist – Fidia Pharma

Join to apply for the Regulatory Affairs Specialist role at Fidia Pharma. Fidia is an Italian multinational pharmaceutical company established in 1946, with research, development, manufacturing, marketing and sales capabilities, and a portfolio of products mainly based on hyaluronic acid, covering joint care, eye care, skin care, specialty care and health & wellness. Headquartered in Abano Terme (PD), Fidia operates in 120+ countries worldwide through local partners and distributors.

About the role

As part of the Regulatory Affairs Team, the candidate will take care of the lifecycle of medicinal products. He/She will prepare regulatory documents, maintain product dossiers, and ensure that updated information is submitted and approved by competent authorities, under supervision of the Manager.

Main Responsibilities

• Management of 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.
• Monitoring, individuation, analysis and evaluation of the impact of new regulatory requirements.
• Revision and submission to the Italian HAs of the medicinal product promotional materials for HCPs and public.
• Maintenance of the compliance of the regulatory documentation with respect to the manufacturing of API and finish products performed in Fidia plants and CMOs.
• Contacts with the CAs and subsidiaries/distributors as well as other Fidia HQ functions to coordinate all regulatory practices.

Requirements

• Bachelor’s degree in Life Science disciplines, preferably in Pharmacy/CTF/Biological Sciences/Chemistry. A specialisation in Regulatory Affairs is a plus.
• At least 5 years’ experience in the regulatory field with a focus on medicinal products, preferably in companies with a manufacturing site for medicinal products.
• Knowledge of medicines legislation, GMP and reference guidelines.
• Experience of managing national procedures and using the various AIFA portal applications.
• Experience of European registrations is a plus.
• Excellent experience of the MS Office package and good experience of preparing eCTD sequences using eCTD Manager or similar software.
• Fluent in both spoken and written English.
• Skills of team working, critical thinking and planning, meeting deadlines efficiently.

Our offer

• Open ended contract.
• “B” grading of Chemical Pharmaceutical National Collective Agreement.
• Salary between € 38.900 and 45.500.
• Collective Bonus and company Welfare.

Benefits & Training

Unlimited access to training and coaching programs aligned with market best practices and opportunities for professional development, internal job postings, pension fund with company integration and health fund, merit review and referral programs, company canteen, staff discounts and access to the flu vaccination campaign.

EEO Statement

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 above; any divergences should be promptly brought to the attention of the People & Culture Department.