
Pharmaceutical Regulatory Affairs Specialist
2 semanas atrás
This role will oversee the entire drug registration process, ensuring timely and efficient submissions in accordance with regulatory requirements. Key responsibilities include preparing and submitting new product and line-extension submissions, post-approvals changes, annual product reviews, and product renewals.
- Prepare, submit and support New Product and Line-Extension submissions, ensuring compliance with relevant regulations.
- Oversee Post-Approvals Changes, Annual Product Review and Product Renewals process, guaranteeing successful regulatory submission and approval of new products.
- Ensure registered products are maintained and updated in full compliance with all relevant legislation and SOPs.
- Collaborate with teams internally and external bodies to meet business objectives, providing expert regulatory input to strategic decision making.
The ideal candidate should have a strong knowledge of current Brazil regulations, fluency in written and spoken English, and a pharmacy degree from an accredited Brazilian University.
- A minimum of 4 years of work experience in regulatory affairs in pharmaceutical Industry is required.
- Planning/Organizing oriented, demonstrate initiative, communication and interpersonal skills.
- Fosters Teamwork
- Provides and Solicits Honest and Actionable Feedback
- Self-Awareness
- Acts Inclusively
- Demonstrates Initiative
- Results-Oriented
Responsibilities may include audits, regulatory agency inspections, or product recalls, as well as maintaining company operating licenses valid with local Health Authority and Anvisa.
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