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Regulatory Affairs Specialist
2 semanas atrás
We are seeking an experienced professional to fill a key regulatory affairs position in São Paulo, Brazil.
Job Responsibilities:
- Assess regulatory requirements for clients' products in Brazil and ensure compliance.
- Prepare and submit regulatory submissions to Brazilian regulatory authorities.
- Provide guidance on regulatory compliance and best practices.
- Maintain accurate and organized regulatory documentation.
- Participate in regulatory agency inspections and audits as needed.
Key Qualifications:
- Bachelor's degree in pharmacy, chemistry, or related field.
- At least 2 years of experience in regulatory affairs within the pharmaceutical industry in Brazil.
- In-depth knowledge of Brazilian regulatory requirements and submission processes.
- Strong understanding of pharmaceutical product development and manufacturing processes.
- Excellent communication and interpersonal skills.
- Ability to work independently and as part of a team.
- Fluency in Portuguese and English.