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Regulatory Affairs Associate
Há 1 mês
As a Regulatory Affairs Associate at Parexel Consulting, you will support clinical trial submissions to regulatory authorities, focusing on projects in Brazil. This role offers an opportunity to develop skills in regulatory affairs and clinical research while working with experienced professionals.
**Key Responsibilities**:
- Contribute to high-quality regulatory deliverables at the country level.
- Support clinical trial submissions to ANVISA (DDCM/DEEC).
- Assist in forecasting submission and approval timelines.
- Support compliance efforts and track milestone progress.
- Identify and communicate potential delays to senior team members.
- Maintain up-to-date training records and ensure timesheet compliance.
- Support TMF document submissions.
- Collaborate with team members on regulatory tasks.
- Assist in communications with the study team.
- Support day-to-day departmental/project activities.
- Help monitor ongoing submissions, amendments, and periodic notifications.
**Qualifications and Skills**:
- Bachelor's Degree in a Scientific or Technical Discipline.
- Basic knowledge of Parexel Consulting's services, models, and methodologies.
- Technical competence in regulatory affairs.
- Understanding of clinical trial regulatory processes.
- Ability to work under Project Leads and Technical SMEs.
- Strong attention to detail and commitment to quality.
- Excellent time management and organizational skills.
- Proficiency in Microsoft Office.
- Good oral and written communication skills.
- Proficiency in Portuguese and English.
**Preferred Qualifications**:
- Previous experience in submitting clinical trials to ANVISA (DDCM/DEEC).
- Familiarity with Brazilian regulatory requirements for clinical trials.
- Initial years of experience in an industry-related environment.
**What We Offer**:
- Mentorship and support from experienced professionals.
- Opportunities for skill development.
- Hands-on experience in regulatory affairs and clinical trial submissions.
- Collaborative team environment.
**Company Commitment**: At Parexel Consulting, we are committed to nurturing talent and providing a supportive environment for our associates to thrive.
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