Regulatory Affairs Senior Associate
hace 4 semanas
Job Summary
Amgen Sa is seeking a highly skilled Regulatory Affairs Senior Associate to join our team. As a key member of our regulatory affairs department, you will play a critical role in ensuring the timely and compliant submission of regulatory documents for our products in Mexico.
Key Responsibilities
- Develop and execute the filing plan for Mexico, ensuring compliance with local and corporate regulatory requirements.
- Prepare and review source text for Mexico country-specific labeling, ensuring accuracy and compliance.
- Review and approve promotion and non-promotion materials, ensuring they meet regulatory requirements.
- Communicate effectively with cross-functional teams to ensure timely and accurate exchange of regulatory information.
- Collaborate with regulatory colleagues and cross-functional teams to improve local regulatory processes and procedures.
- Update and maintain internal regulatory systems and tracking tools, ensuring compliance with internal policies and standard operating procedures.
- Develop and execute the local strategy to obtain new Marketing Authorizations for assigned business units, ensuring compliance with local and current regulations and procedures.
- Analyze technical, scientific, and legal information to prepare dossiers for innovative products, ensuring compliance with all applicable requirements and guidelines.
Requirements
- Master's degree or equivalent in a relevant field, or Bachelor's degree with 2 years of experience in a similar role.
- Proficiency in English, both in oral and written communication.
About Amgen Sa
Amgen Sa is a global biotechnology company dedicated to serving patients through the discovery, development, and delivery of innovative medicines. We are committed to making a meaningful difference in the lives of patients and to advancing the field of biotechnology.
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