Global CMC Regulatory Director - Medical Devices & Combos

Organon Comercializadora S de RL de C.V; Harmonville (PA); Presencial; USD 180.000 - 240.000; Tempo integral

Resumo da vaga

Organon Comercializadora S de RL de C.V in Harmonville, PA seeks a Principal Scientist (Director), CMC Regulatory Affairs for Medical Devices & Combination Products. You will provide strategic leadership for global regulatory activities across development, registration, and lifecycle management.

This senior role requires navigating evolving regulations, shaping global regulatory strategy, and influencing development and manufacturing decisions to ensure patient access and uninterrupted product

Qualificações

• Bachelor's degree or higher in Engineering, Pharmacy, Pharmaceutical Sciences, Biology, or Chemistry.

Responsabilidades

• Develop and lead global CMC regulatory strategies for medical devices and drug-device combination products across all stages of the product lifecycle.
• Drive regulatory approaches supporting development, clinical investigation, registration, commercialization, lifecycle management, and patient supply continuity.
• Provide strategic regulatory guidance for complex device technologies, delivery systems, connected devices, and combination products.
• Anticipate regulatory risks and develop mitigation strategies to support program objectives and business priorities.
• Lead resolution of complex regulatory issues where regulations are evolving or established regulatory precedent is limited.
• Lead regulatory strategy and execution for major submissions and regulatory milestones, including INDs/CTAs, NDAs/BLAs/MAAs, device documentation, and post-approval changes.
• Oversee regulatory impact assessments for manufacturing, design, process, packaging, labeling, and device constituent changes.
• Ensure regulatory requirements are integrated into development plans, control strategies, and commercialization activities.
• Represent Regulatory Affairs during interactions with FDA, EMA, Health Canada, Notified Bodies, and other global agencies.
• Lead strategy development, briefing preparation, agency responses, and regulatory negotiations.
• Provide leadership during inspections, audits, and regulatory inquiries involving device and combination product requirements.
• Influence regulatory approaches through engagement with health authorities and industry stakeholders.

Formação

Bachelor's degree or higher in Engineering, Pharmacy, Pharmaceutical Sciences, Biology, Chemistry

Descrição da vaga

Organon Comercializadora S de RL de C.V in Harmonville, PA seeks a Principal Scientist (Director), CMC Regulatory Affairs for Medical Devices & Combination Products. You will provide strategic leadership for global regulatory activities across development, registration, and lifecycle management.

This senior role requires navigating evolving regulations, shaping global regulatory strategy, and influencing development and manufacturing decisions to ensure patient access and uninterrupted product