Job Description

, permanent
Position: Analista de Assuntos Regulatórios
PharmEng Technology is a leading pharmaceutical consulting firm specializing in regulatory affairs, quality assurance, and compliance. We are currently seeking a highly motivated and experienced Analista de Assuntos Regulatórios to join our team in São Paulo, Brazil.
As an Analista de Assuntos Regulatórios, you will be responsible for ensuring that our clients' products comply with all applicable regulatory requirements in Brazil. This includes conducting regulatory assessments, preparing and submitting regulatory submissions, and providing guidance on regulatory compliance. You will also be responsible for maintaining up-to-date knowledge of regulatory requirements and changes in the pharmaceutical industry.
Key Responsibilities:
- Conduct regulatory assessments to determine the regulatory requirements for our clients' products in Brazil
- Prepare and submit regulatory submissions to the Brazilian regulatory authorities
- Provide guidance and support to clients on regulatory compliance
- Monitor and stay up-to-date with changes in Brazilian regulatory requirements and communicate these changes to clients and internal teams
- Collaborate with cross-functional teams to ensure timely and accurate completion of regulatory submissions
- Maintain accurate and organized regulatory documentation
- Participate in regulatory agency inspections and audits as needed
- Contribute to the development and improvement of regulatory processes and procedures
Qualifications:
- Bachelor's degree in pharmacy, chemistry, or a related field
- Minimum of 2 years of experience in regulatory affairs in the pharmaceutical industry in Brazil
- 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 in a team environment
- Fluency in Portuguese and English is required
We offer a competitive salary and benefits package, as well as opportunities for professional growth and development. If you are a highly motivated individual with a passion for regulatory affairs, we want to hear from you! Apply now to join our dynamic team at PharmEng Technology.