Regulatory Affairs Specialist
1 dia atrás
**Job Summary:**
We are seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our operations, you will be responsible for ensuring compliance with regulatory requirements and maintaining necessary licenses and certifications.
- Maintain GMP Certification process according to ANVISA regulations;
- Maintain necessary regulatory-associated licenses such as sanitary license, GMP certificate and operating authorizations updated and obligations with national agencies;
- Provide RA guidance to key departments: QA, Marketing, Medical, Importation and Customer Service;
Key Responsibilities:
- Review and approval of packaging and promotional materials in accordance with national legislation and the Code of Responsible Business Practices (CRBP);
- Closely collaborate with Global RA and local PhV and Quality Assurance teams;
- Oversight of external regulatory services providers: documentation assessment and sharing, liaise with global regulatory team to provide support to external providers, verify the quality of processes, activities and payment of external providers;
Requirements:
- Graduation in Pharmacy;
- Post-graduation is desirable;
- Fluency in English;
- Good computer skills;
- Minimum of 5 years of relevant experience as RA Analyst in pharmaceutical industry;
Benefits:
We encourage you to make your well-being a priority. It's important and so are you.
About Us:
We are a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases.
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