Regulatory Affairs Manager - CMC biologics (various European locations)

TN Italy; Italia; Remoto; EUR 50.000 - 90.000; Tempo pieno

Descrizione del lavoro

An established industry player is seeking an experienced CMC Regulatory Manager to join their dynamic team. This remote role focuses on post-approval regulatory activities for biological products, where you'll develop strategies for submissions and ensure compliance with regulatory requirements. If you have a strong background in regulatory affairs and a passion for the pharmaceutical industry, this is an exciting opportunity to make a significant impact. Join a forward-thinking company that values teamwork and innovation, and help shape the future of healthcare.

Competenze

• Experience in regulatory affairs, particularly in CMC within the pharmaceutical industry.
• Strong understanding of post-approval regulatory requirements.

Mansioni

• Develop submission strategies for post-approval CMC activities.
• Coordinate submission preparation with various departments.

Conoscenze

Regulatory Affairs

CMC Knowledge

Quality Assurance

Project Management

Communication Skills

Team Spirit

Formazione

University-level education in Life Sciences

Strumenti

Word

PowerPoint

Excel

Veeva Vault

Descrizione del lavoro

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Regulatory Affairs Manager - CMC biologics (various European locations), remote, italy

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Client:

Parexel

Location:

Job Category:

Other

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EU work permit required:

Yes

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Job Reference:

d43322f320a1

Job Views:

4

Posted:

06.05.2025

Expiry Date:

20.06.2025

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Job Description:

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

Are you an experienced regulatory professional looking for a new opportunity? We are currently seeking a talented CMC Regulatory Manager (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 CMC Regulatory Manager, 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 and 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.
• Fluent in English (written and spoken). French, Italian and German would be a strong plus.