Regulatory Compliance Manager
7 giorni fa
About the Role
We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Page Personnel. As a key member of our team, you will be responsible for managing and preparing regulatory dossiers for submissions of human drug substances to various regulatory authorities.
Key Responsibilities
- Manage and prepare regulatory dossiers (CTD) for submissions to US, EU, and other regulatory authorities.
- Prepare and manage dossiers in response to deficiency letters from regulatory authorities and in accordance with applicable changes.
- Manage and prepare renewals and annual reports.
- Evaluate changes and ensure compliance with regulatory requirements.
- Support the management of customer variations and regulatory strategy for Investigational Medicinal Products (IMPD).
- Evaluate and edit Standard Operating Procedures (SOPs).
Requirements
- Hold a degree in a scientific subject.
- Have experience in regulatory affairs in a pharmaceutical company.
About Us
Page Personnel is a leading recruitment agency that believes in diversity and inclusion. We promote equal opportunities and do not discriminate based on sex, race, age, religion, sexual orientation, or any other aspect that may be considered discriminatory.
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