CMC Expert Professional
1 week ago
Job Overview:
- Parexel is currently seeking a talented Compliance Manager to join our global team in this client-dedicated project.
Role Description:
- This role will play a vital part in our company's worldwide post-approval regulatory activities, focusing on Chemistry, Manufacturing, and Controls (CMC) for biological products.
Responsibilities:
- Plan and execute post-approval CMC activities, including variation, renewal, market expansion, and annual report submissions.
- Lead the assessment of change controls and provide regulatory expertise for quality changes in production and quality control.
- Review study reports from the quality control and production departments to ensure compliance with regulatory requirements.
- Collaborate with cross-functional teams to prepare submission content and manage Regulatory Information Management systems.
- Write and review submission content to ensure alignment with regulatory requirements.
- Identify and mitigate risks associated with regulatory procedures and activities.
Qualifications:
- Bachelor's degree in a relevant field, such as Life Sciences.
- Proven experience in regulatory affairs, particularly in technical/CMC/quality roles within the pharmaceutical industry.
- Strong understanding of CMC and post-approval regulatory requirements.
- Excellent communication and interpersonal skills.
- Proficiency in Microsoft Office Suite and Veeva Vault.
- Fluency in English, with additional languages (e.g., French, Italian, German) being an asset.
Benefits:
- A competitive salary package, estimated at €90,000 - €130,000 per annum.
- A comprehensive benefits program, including health insurance, retirement plan, and paid time off.
- Ongoing training and professional development opportunities.
- A collaborative and dynamic work environment.
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