Coordenador regulatório cmc – São Paulo/SP

SP | São Paulo
Efetivo (CLT)
Biólogo
Bioquímico
Engenheiro Químico
Farmacêutico

Key Responsibilities

• Coordinate and provide to LOCs the CMC documentation according to the defined regulatory strategy, aligning timelines between manufacturing sites and LOCs, aiming to support the filings required during products lifecycle (new licenses applications , post-approval changes) and innovation for the assigned products.
• Author technical dossier in CTDformat (ICH Module 3) or other local required format, according to the defined regulatory strategy.
• Assess change control process for the products to which it is assigned, thereby ensuring compliance with GMP and approved dossiers by BoH to conditions in place at manufacturing sites.
• Review CMC CTD format component packages for accuracy and completeness for regulatory requirements and compliance with originating site documentation in support of filings of new license applications and post-approval changes.
• Update and maintain compliance of product dossier and change control management systems and/or databases according internal SOPs / SLA´s.
• Serve as a quality-wise Subject Matter Expert point of contact for the products to which it is assigned, supporting generation of technical justification and product information audits as needed.
• Support LOCs with technical expertise for emerging regulations/updates in place, and even represent the company externally at trade association meetings where technical expertise quality-wise is required.
• KPIs measurement for processes in charge accordingly.
• Guarantee compliance activities accomplishment for the role (e.g. documentation management, CMC, SOP, WI, etc.

Basic Qualifications

• Graduation in Chemistry, Pharmacy, Biochemistry, Biology, Chemical Engineer.
• Master Degree is a plus.
• Excellent interpersonal and communication skills, with the ability to influence and build relationships with stakeholders at all levels.
• Experience work with ANVISA with Technical Justification.
• Demonstrated ability to manage multiple priorities, manage LATAM team, work under pressure, and deliver results in a fast-paced environment.
• English is mandatory Advanced and Spanish is desirable.