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Regulatory Compliance Officer
hace 2 semanas
We are seeking a Senior Associate Regulatory Affairs Fixed Term for a 2-year term. This role will be responsible for ensuring regulatory submissions meet Amgen's corporate and local regulatory requirements. Key responsibilities include contributing to the filing plan for LatAm countries, preparing country-specific labeling, reviewing and approving promotion materials, communicating relevant information to teams, participating in local regulatory process improvement initiatives, and providing advice on local regulatory considerations.
Key Responsibilities
- Ensure regulatory submissions are made on time and meet Amgen's corporate and local regulatory requirements.
- Contribute, implement, and execute the filing plan for LatAm where applicable.
- Prepare, review & approve source text for LatAm country-specific labeling.
- Review & approve promotion and non-promotion materials.
- Communicate relevant information to team(s) in advance.
- Participate and give input in local regulatory process improvement initiatives.
- Collate, distribute and exchange regulatory information with other regulatory colleagues and cross-functional teams on an ongoing basis and provide advice on local regulatory considerations in a timely manner.
- Update, maintain internal regulatory systems and tracking tools in accordance with internal policies and standard operating procedures.
- Develop & execute the local strategy to obtain the new Marketing Authorizations of the assigned business unit, ensuring compliance with local and current regulations and procedures.
- Analyze technical, scientific, and legal information to prepare dossiers of innovative products, complying with all applicable requirements and guidelines, avoiding preventions by the health authority (New Marketing Authorizations, technical and administrative variations, and renewals).
- Collaborate with International Regulatory Leads (IRLs), CMC, and other functions to support the regulatory strategy, registration, timelines, and lifecycle management of all Amgen molecules.
