Senior Regulatory Affairs Associate - CMC biologics/vaccines

Responsibilities

• Develop submission strategies and plans for post-approval CMC activities, including variations, renewals, market expansions, and annual reports.
• Assess change controls and provide regulatory assessments regarding quality changes in production and quality control.
• Review study reports from quality control and production departments to ensure full compliance with regulatory requirements.
• Coordinate submission preparation across various departments such as manufacturing, supply chain, quality control, and quality assurance.
• Write and review CMC technical submission content to ensure alignment with regulatory requirements and health authority queries.
• Manage projects within Regulatory Information Management systems to maintain worldwide submissions.
• Identify, escalate, and mitigate risks associated with regulatory procedures and activities.

Requirements

• University-level education, preferably in Life Sciences, or equivalent experience.
• Previous experience in regulatory affairs, specifically related to technical CMC or quality within the pharmaceutical industry.
• Strong understanding of CMC and post-approval regulatory requirements.
• Proven experience writing CMC technical sections of regulatory documents, such as registration files or variations.
• Knowledge of biological or vaccine manufacturing processes.
• Background in validation, Quality Assurance, or production within the pharmaceutical industry.
• Proficiency in Microsoft Office (Word, PowerPoint, Excel) and experience with Veeva Vault is highly valued.
• Fluency in written and spoken English.

Preferred Qualifications

• Experience with qualification and validation principles.
• Strong organizational skills and the ability to work effectively in a team-oriented, remote environment.

About the Company

Parexel is a global leader in clinical research, helping biopharmaceutical and medical device companies navigate complex regulatory landscapes. Through Parexel Consulting, we provide scientific and technical expertise to bring life-changing products to market faster. We pride ourselves on a supportive, inclusive, and flexible work culture that prioritizes patient-led results and continuous professional growth.