Regulatory Affairs Specialist

Accord Healthcare; Italia; In loco; EUR 40.000 - 60.000; Tempo pieno

Descrizione del lavoro

Accord Healthcare in Italy is seeking a Regulatory Affairs Specialist to support local regulatory workflows, prepare dossiers and applications for new registrations, and maintain product life-cycle management under supervision.

You will work with RA and QA teams, coordinate parallel import filings, liaise with regulatory authorities, manage Life Cycle Management changes, and ensure artwork and marketing materials meet regulatory standards.

Competenze

• At least 6 months to 1 year of professional experience in a similar position or internship in a regulatory affairs department within a pharmaceutical company or a national competent authority.

Mansioni

• Prepare dossiers and applications to register new products and maintain existing product life-cycle.
• Prepare parallel import applications for national and central import procedures.
• Support relationships with local regulatory authorities to achieve positive outcomes for new product registrations, variations, renewals, notifications.
• Submit Life Cycle Management changes (variations, marketing status, sunset clause, renewals and line extensions).
• Coordinate artwork revision process, including requesting, proofreading, approval and implementation from a regulatory perspective.
• Collaborate with supply chain and marketing to ensure product launches and marketing materials comply with regulatory requirements.

Conoscenze

Regulatory knowledge

Regulatory liaison

Descrizione del lavoro

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Job Title: Regulatory Affairs Specialist

Job Requisitions No.: 18302

Job Description:

Role Details

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.

The Role

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.

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

The Rewards

A Bit About Us

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All applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or disability.

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