Regulatory Affairs Specialist

Founded in 1946, Fidia is an Italian multinational pharmaceutical company, with R&D, manufacturing, marketing and sales capabilities, and an extensive product portfolio, mainly based on Hyaluronic Acid, in strategic therapeutic areas such as Joint care, Eye care, Skin care, Specialty care, Health&Wellness care. Headquartered in Abano Terme (PD), Fidia extends its global reach through local partners and distributors in 120+ countries worldwide, as well as with wholly owned subsidiaries.

We are recruiting a

Regulatory Affairs Specialist

Being part of the Regulatory Affairs Team, the candidate will take care of the lifecycle of the medicinal products. He/she will be in charge of preparing regulatory documents for medicinal products, maintaining the product dossiers to guarantee that the most updated information is submitted and approved by the concerned Competent Authorities, with the 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 € and
• Collective Bonus and company Welfare.

Fidia benefits:

In Fidia you will have unlimited access to training and coaching programs aligned with market best practices and 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.