Senior Regulatory Affairs Associate - CMC biologics/vaccines (home or office based)

Parexel; Polska; Hybrid; PLN 180,000 - 240,000; Full time

Benefits offered by this job

Remote work

Job summary

Parexel is seeking a Senior Regulatory Affairs Associate to join our global regulatory team. The role focuses on post-approval CMC activities for biological and vaccines products, with office or home-based options in Europe.

You will develop submission strategies, review changes, coordinate cross-functional submissions, and manage Regulatory Information Management systems to ensure worldwide registrations.

Qualifications

• University-level education in Life Sciences or equivalent by experience.
• Experience in regulatory affairs, particularly related to technical/CMC/quality within the pharmaceutical industry.
• Strong understanding of CMC and post-approval regulatory requirements.

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 to ensure compliance with regulatory requirements.
• Coordinate submission preparation with manufacturing, supply chain, quality control and other regulatory departments.
• Write and/or review submission content to ensure alignment with regulatory requirements for variations and health authority questions.
• Manage projects within Regulatory Information Management systems and maintain worldwide submissions.
• Identify, escalate, and mitigate risks associated with regulatory procedures and activities.

Skills

Regulatory affairs

CMC knowledge

Quality documentation

Regulatory submissions

Education

University degree in Life Sciences

Tools

Veeva Vault

Microsoft Word

PowerPoint

Excel

Job description

Are you an experienced regulatory affairs professional looking for a new opportunity? We are currently seeking a talented Senior Regulatory Affairs Associate 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 Senior Regulatory Affairs Associate 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 and vaccines 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, escalated, 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 or vaccines 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).

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