Internship Regulatory Affairs

Accord Healthcare; Milano; In loco; EUR 30.000 - 50.000; Tempo pieno

Descrizione del lavoro

Accord Healthcare in Milano is seeking an entry to mid-level Regulatory Affairs professional to support dossier preparation and registration activities. The role involves maintaining product life-cycle, coordinating with local authorities, and ensuring compliance for launches and marketing materials from a regulatory perspective.

The candidate should have 6–12 months or more of RA experience, knowledge of pharmaceutical law, and an understanding of registration and reimbursement procedures.

Competenze

• Experience in regulatory affairs or internship in pharma is required.
• Knowledge of pharmaceutical law and doc requirements is essential.
• Understanding of registration and reimbursement procedures is expected.
• Strong analytical skills and well organized with flexibility.

Mansioni

• Prepare dossiers and applications to register new products and maintain life-cycle.
• Prepare parallel import applications for national and central procedures.
• Support relationships with local regulatory authorities to achieve registrations.
• Submit Life Cycle Management changes and variations, renewals, and sunset clauses.
• Coordinate artwork revision, proofreading, approval and implementation.
• Collaborate with supply chain and marketing for regulatory approvals on launches.
• Maintain and coordinate local databases and product master data.
• Liaise with HQ RA to prioritize new procedures and changes.
• Support Tender Dept. with quality and regulatory documentation.

Conoscenze

Regulatory affairs

Analytical skills

Organization

MS Office (Excel)

English (B2)

Communication

Formazione

Bachelor in Pharmacy/Biotechnology/Chemistry

Master in Regulatory Affairs (plus)

Strumenti

MS Office

Excel

Descrizione del lavoro

The role has primary responsibility for supporting all local regulatory affairs workflow including preparation of dossiers and applications for new registration and maintain existing products life-cycle as well as applying the pharmacovigilance policy under the supervision by line Manager.

Support RA and QA team in:

• Preparation of dossiers and applications to register new products and maintain existing products life- cycle
• Preparation of parallel import applications for national and central import procedures.
• Supporting the relationships with local regulatory authorities to achieve positive outcomes for new product registrations, variations, renewals, notifications.
• Submission of Life Cycle Management changes (variations, marketing status, sunset clause, renewals and line extensions)
• Artwork revision process, i.e. requesting, proof reading, approval and implementation of artwork
• Close cooperation with supply chain and marketing department to ensure product launch and marketing materials approval from regulatory perspective.
• Maintain and coordinate various local databases.
• Close contact with headquarters RA department to prioritize the new procedures and upcoming changes.
• Support to Tender Dept. for qualitative related documentation.
• Maintenance of RA/QA internal databases and product master data
• Support with PQC and MI

The person

• At least 6 months 1-year professional experience on similar position or internship in RA Department in pharmaceutical company or national competent authority
• Knowledge of pharmaceutical law and the required documentation for pharmaceutical product
• An understanding of the drug registration and reimbursement procedures
• Strong analytical skills
• Being well organized and flexible
• Excellent knowledge of MS Office, especially Excel
• Fluent English (B2 is minimum)

Clearly define any essential or desirable

• Qualifications: pharmacy, biotechnology, biology, chemistry or similar.
• Certifications or accreditations: Master concerning Regulatory Affairs and P&R could be a plus

Those listed as essential will form part of the key criteria for selecting candidates for the role.