Associate Director
hace 3 semanas
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.
-
Associate Account Director
hace 3 semanas
Mexico City Mindgruve A tiempo completoASSOCIATE ACCOUNT DIRECTOR El Associate Account Director lidera cuentas clave o un grupo de clientes medianos. Este rol combina estrategia, gestión financiera y liderazgo de equipo. Su objetivo es fortalecer la relación con los clientes, impulsar el crecimiento y asegurar que el trabajo entregado sea claro, efectivo y alineado con las metas del negocio....
-
Associate Account Director
hace 3 semanas
Mexico City Mindgruve A tiempo completoASSOCIATE ACCOUNT DIRECTOR El Associate Account Director lidera cuentas clave o un grupo de clientes medianos. Este rol combina estrategia, gestión financiera y liderazgo de equipo. Su objetivo es fortalecer la relación con los clientes, impulsar el crecimiento y asegurar que el trabajo entregado sea claro, efectivo y alineado con las metas del negocio....
-
Associate Director
hace 2 semanas
Mexico Avance Consulting A tiempo completoJob Title: Associate Director – Regional CMCLocation: Remote (Mexico/Colombia)Job Type: PermanentPosition 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...
-
Associate Director- Project Finance Advisory
hace 24 horas
Mexico City Gridlines A tiempo completoCompany Overview Gridlines is a young, entrepreneurial, fast‑growing financial advisory and financial modelling firm. The company formally launched its infrastructure advisory business last year, focusing on project finance, M&A and bid support across all infrastructure sectors, with a particular focus on energy transition projects. Role Overview This role...
-
Associate Director- Project Finance Advisory
hace 22 horas
Mexico City Gridlines A tiempo completoCompany Overview Gridlines is a young, entrepreneurial, fast‑growing financial advisory and financial modelling firm. The company formally launched its infrastructure advisory business last year, focusing on project finance, M&A and bid support across all infrastructure sectors, with a particular focus on energy transition projects. Role Overview This role...
-
Associate Director, Product Design
hace 2 semanas
Mexico City DesignOps Latam A tiempo completoMethod busca un/a Associate Director, Product Design en Ciudad de México para liderar equipos multidisciplinarios, desarrollar estrategias de diseño y colaborar con clientes en la creación de experiencias digitales innovadoras. Servicios (Tecnología / Diseño) Method es una consultora global de diseño y desarrollo de productos digitales fundada en 1999....
-
Associate Director, Product Design
hace 3 semanas
Mexico City DesignOps Latam A tiempo completoMethod busca un/a Associate Director, Product Design en Ciudad de México para liderar equipos multidisciplinarios, desarrollar estrategias de diseño y colaborar con clientes en la creación de experiencias digitales innovadoras. Servicios (Tecnología / Diseño) Method es una consultora global de diseño y desarrollo de productos digitales fundada en 1999....
-
Associate Director
hace 3 semanas
Mexico City Avance Consulting A tiempo completoJob 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...
-
Associate Director, U.S. Launch Excellence
hace 3 semanas
Mexico City Novartis Farmacéutica A tiempo completoChoose LocationChoose Location# Associate Director, U.S. Launch ExcellenceREQ-10068036Dec 09, 2025Mexico### SummaryNovartis is preparing to launch several innovative medicines in the U.S. across four therapeutic areas over the next five years. To drive successful launches, we are seeking an Associate Director to join the U.S. Launch Excellence Capabilities &...
-
Associate Director, Organization Transformation
hace 3 semanas
Mexico City Novartis México A tiempo completoA leading pharmaceutical company in Mexico, is seeking an Associate Director for Organization Development. This role involves leading strategic initiatives to solve complex organizational challenges and drive transformation. The ideal candidate will have extensive experience in organizational development, change management, and possess strong stakeholder...
