Associate Director

hace 20 horas

México Avance Consulting A tiempo completo

Job Title: Associate Director – Regional CMC Location: Remote (Mexico/Colombia) Job Type: Permanent Position Overview : The Associate Director – Regional CMC connects with global Regulatory CMC teams and with local affiliates, driving regional alignment and efficiency in post-approval submissions. This role supports a diverse product portfolio, including small molecules, biologics, vaccines, and plasma-derived therapies, ensuring submission packages are developed and distributed with a regionalized approach. This role is instrumental in driving efficiency and consistency across countries within the region by leveraging regional strategies and aligning with global submission plans. Primary Responsibilities: Act as the primary point of contact between global Regulatory CMC and local affiliates for submission package preparation and delivery. Translate global CMC strategies into actionable regional plans, ensuring alignment with country-specific requirements. Oversee the preparation, review, and submission of regulatory dossiers across the region. Develop and implement regional submission strategies to streamline processes and reduce duplication of effort. Partner with affiliates to identify opportunities for harmonization across the region. Build strong relationships with local affiliates to understand country-specific regulatory needs and challenges. Liaise with global Regulatory CMC teams to provide regional insights and feedback. Identify bottlenecks in the regional submission process and propose innovative solutions to enhance efficiency. Monitor and report on submission timelines and regulatory approvals across the region. Education & Competencies (Technical and Behavioral): A BS/BA degree in a scientific discipline or an advanced degree (M.S., Ph.D., etc.) is preferred. 10+ years of overall biopharmaceutical/device industry experience with 5+ years of pharmaceutical Regulatory CMC or Device experience is preferred, including experience leading a major variation/amendment, supporting an initial IND/IMPD preparation, or supporting an initial NDA/BLA. Equivalent industry experience in Pharmaceutical Development, Analytical Development, Production, and Quality Assurance can be considered. Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support. Proven ability to understand and communicate regulatory strategy to drug development, registration, and post-market support teams. Analyze issues with attention to detail. Base regulatory strategy recommendations on precedents and other regulatory intelligence as well as regulations and guidelines. Able to deal with issues of critical importance with minimal supervision. Exercises good judgment in elevating and communicating actual or potential issues to line management. Understands who is responsible for different decisions and escalates as necessary. Implements the decisions taken by the company. Demonstrates emerging leadership, problem-solving ability, flexibility, and values teamwork. Intentionally promotes an inclusive culture. Applies the given prioritization framework with limited support. Excellent written and oral communication skills required. Exercises good judgment in elevating and communicating actual or potential issues to line management.

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