Regulatory Affairs Expert

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, Skin Care, Eye Care, Health&Wellness Care, Specialty Care, Regenerative Care and Aesthetic Care. Headquartered in Abano Terme (PD), Fidia extends its global reach through local partners and distributors in 120+ countries worldwide, as well as wholly own subsidiaries.

We are recruiting a

Regulatory Affairs Expert

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 worldwide.

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.
• Maintenance of the internal and external databases.
• Contacts with subsidiaries/distributors worldwide to get information on requirements for planning regulatory activities.
• Contacts with other Fidia HQ departments and affiliates functions to support the team in all regulatory activities.

Requirements:

• Degree in Life Science disciplines, preferably in Pharmacy or CTF, Biological Sciences, Chemistry. A specialization in Regulatory Affairs is a plus.
• At least 1 year of experience in the regulatory field with a focus on medicinal products, preferably in companies with a manufacturing site for medicinal products.
• Knowledge of pharmaceutical regulations, GMP and relevant guidelines.
• Experience in managing national or European registrations (DCP, MRP).
• Excellent proficiency in MS Office and preferable knowledge of eCTD Manager.
• Excellent knowledge of written and spoken English.
• Strong teamwork, active listening, accuracy, flexibility, and ability to learn.

Our offer:

• Open ended contract.
• Salary between € 30.500 and 38.000.
• 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.