Regulatory Affairs Specialist, LATAM – São Paulo/SP

SP | São Paulo
Efetivo (CLT)
Biólogo
Biomédico
Bioquímico
Biotecnologista
Farmacêutico

Responsabilities

• Assist Manager, Regulatory Affairs, in assuming primary or secondary regulatory responsibility for assigned clinical research projects by providing regulatory information, guidance, training, support and strategic planning based on applicable regulations and guidances issued by the applicable regulatory agency(ies) to the project team.
• Identify and interpret regulations, guidelines, and other pertinent information issued by applicable regulatory agencies and other regulatory organizations.
• Leads the preparation, submission and maintenance of regulatory filings with relevant health authorities
• Write/compile, and review high-quality CMC modules for development applications, and amendments, for submission, ensuring complete CMC content that meets current regional requirements and FDA/EU/World Health Authority requirements.
• Leads and supports multidisciplinary teams in the development and authoring of major regulatory documents such as initial IND applications, IND amendments, meeting requests, meeting packages and IMPD etc. Review protocols, consent forms, reports, scientific documents, publications, and related papers, etc., as appropriate for various clinical research projects to ensure compliance with regulations.
• Ensure the compilation and maintenance of pertinent documentation (e.g., files) required for regulatory compliance for assigned clinical research projects.
• Serve as a member of groups, teams, or committees related to regulatory affairs, and quality assurance or other designated IQVIA Biotech activities, as appropriate.
• Serve as company liaison with central IRBs.
• Perform other related duties as assigned.

Requirements

• Requires Bachelor’s degree with at least 3 years of related work experience, with 2 or more years in regulatory affairs, quality assurance and/or clinical research, or equivalent level of education, training and experience.
• Science degree preferred.
• Excellent analytical and communication skills, particularly writing skills, are essential.
• Must be familiar with and able to identify and interpret regulations, guidelines, and other pertinent information issued by applicable regulatory bodies.
• Must be able to independently coordinate with interdisciplinary team members, manage timelines for and compile documents for pre-IND and IND submissions, with oversight from Regulatory Management.
• Demonstrated Clinical, Pre-clinical and or CMC knowledge for chemical or biologic products preferred.
• Demonstrated computer literacy is required.