Regulatory Affairs Consultant - CMC biologics (home or office based)

TN Italy; Italia; Remoto; EUR 50.000 - 70.000; Tempo pieno

Descrizione del lavoro

A leading consulting firm is seeking a Regulatory Affairs Consultant specializing in CMC biologics. This role can be performed remotely or from the office in Italy. You will be responsible for managing post-approval regulatory activities and ensuring compliance with quality standards. Ideal candidates will have a strong background in regulatory affairs within the pharmaceutical industry and excellent organizational skills.

Competenze

• Previous experience in regulatory affairs, particularly in CMC within pharma.
• Strong understanding of post-approval regulatory requirements.

Mansioni

• Develop submission strategies for post-approval CMC activities.
• Review study reports for compliance with regulatory requirements.
• Coordinate submission preparation across various departments.

Conoscenze

Team spirit

Flexibility

Accountability

Organizational skills

Formazione

University-level education in Life Sciences

Strumenti

Word

PowerPoint

Excel

Veeva Vault

Descrizione del lavoro

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Regulatory Affairs Consultant - CMC biologics (home or office based), remote, Italy

Client: Parexel

Location: Italy (home or office based)

Job Category: Consulting

EU work permit required: Yes

Job Reference: 1365af3f0cfe

Job Views: 3

Posted: 15.05.2025

Expiry Date: 29.06.2025

Job Description:

When our values align, there's no limit to what we can achieve.

Are you an experienced regulatory affairs professional looking for a new opportunity? We are currently seeking a talented Regulatory Affairs Consultant to join our dynamic team! This is a client-dedicated project, and the role can be office or home based in various European locations.

As the Regulatory Affairs Consultant, you will play a vital role in our company's worldwide post-approval regulatory activities, specifically focused on Chemistry, Manufacturing, and Controls (CMC) for biological products.

Primary Tasks & Responsibilities:

• Develop submission strategies and plans for post-approval CMC activities such as variations, renewals, market expansions, and annual reports.
• Assess change controls and provide regulatory assessments of quality changes in production and quality control.
• Review study reports from the quality control and production departments to ensure compliance with regulatory requirements.
• Coordinate submission preparation with various departments including manufacturing, supply chain, quality control, quality assurance, and other regulatory departments and local companies.
• Write and/or review submission content to ensure alignment with regulatory requirements, specifically related to variations and questions from health authorities.
• Manage projects within all Regulatory Information Management systems, ensuring the maintenance of worldwide submissions.
• Identify, escalate, and mitigate risks associated with regulatory procedures and activities.

Experience and Knowledge Requirements:

• University-level education, preferably in Life Sciences, or equivalent by experience.
• Previous experience in regulatory affairs, particularly related to technical/CMC/quality, within the pharmaceutical industry.
• Strong understanding of CMC and post-approval regulatory requirements.
• Experience in writing CMC (technical) sections of regulatory documents such as registration files or variations.
• Knowledge of biological processes.
• Background in validation/Quality Assurance/production in the pharmaceutical industry, with experience in preparing regulatory documentation. Understanding of qualification/validation principles.
• Proficiency in Word, PowerPoint, Excel, and experience with Veeva Vault is valued.
• Team spirit, flexibility, accountability, and organizational skills.