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QualificationsPrevious CMC with Biologics is requiredVeeva Vault RIM experience is requiredOpen to NA and LATAM - must work EST hours.ResponsibilitiesConduct research of existing product data relative to general or regional regulatory requirements for the preparation of gap analyses, product development plans, and other regulatory submissions.Manage and/or operationalize the delivery of day‐to‐day regulatory activities for assigned project according to agreed timelines, scope of contract, budgets, and strategies.Participate as regulatory support on multidisciplinary project teams, which may include clinical and other technical experts, to develop products throughout their life cycle.Prepare estimates for conducting regulatory services as part of single or multiple service proposals.Support meetings with clients to discuss proposals, the status of ongoing projects, and as part of general business development activities.Ensure compliance with appropriate general regulatory requirements and the company's policies and processes.Prepare training materials and share best practices in the regulatory area,



both internally and externally.Participate as regulatory support in internal or external project audits.Participate as regulatory support on internal cross‐functional initiatives.Contribute to the creation and/or maintenance of SOPs and other process related documentation as required.Provide support in oversight to team members in the execution of their project responsibilities.Capable of identifying when to ensure line support required to provide additional guidance and direction.Maintenance of individual training records (Syneos Health or client related) and completion of all designated required training.Additional Information: Tasks, duties, and responsibilities as listed in this job description are not exhaustive.
The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities.
Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description.
The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above.
Further, nothing contained herein should be construed to create an employment contract.
Occasionally, required skills/experiences for jobs are expressed in brief terms.
Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.
The Company is committed to compliance with the Americans with Disabilities Act, inclu
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Postúlate en Kit Empleo: kitempleo.com.co/empleo/1b24mf

📌 Regulatory Consultant Cmc - Small Molecule (Bogotá)
🏢 Syneos - Clinical and Corporate - Prod
📍 Bogotá