Regulatory Affairs CMC – Manager/Associate Director/Director

Position Summary

We are seeking an experienced Regulatory Affairs CMC professional to support regulatory strategy and execution for small molecule development programs. The role will provide regulatory CMC leadership across the product lifecycle—from pre-IND through post-approval—ensuring high-quality CMC submissions and alignment with global health authority requirements.

The level of the role (Manager, Associate Director, or Director) will be determined based on experience and demonstrated expertise.

Responsibilities

Regulatory Strategy & Leadership
- Develop and execute general regulatory CMC strategies to support small molecule programs through all phases of development and commercialization.
- Serve as the primary CMC regulatory contact for internal teams and external partners, ensuring alignment of regulatory strategies with program objectives.
- Interpret and apply global CMC regulations, guidelines, and precedents to drug substance and drug product development.
- Engage with health authorities (FDA, EMA,



PMDA, etc.) on CMC matters, including preparation of meeting briefing documents and leading discussions as appropriate.

Submission Development & Lifecycle Management
- Author, review, and manage CMC sections of regulatory submissions, including INDs/CTAs, NDAs/MAAs, IMPDs, Annual Reports, and post-approval supplements/variations.
- Ensure accuracy, scientific integrity, and compliance with applicable regulations and company standards.
- Support change control assessments and contribute to regulatory impact analyses.
- Maintain oversight of submission timelines, proactively identifying risks and mitigation strategies.

Cross-Functional Collaboration
- Partner with Technical Development, Manufacturing, Quality, and Project Management to ensure regulatory requirements are integrated into CMC development and lifecycle plans.
- Provide regulatory guidance on analytical methods, specifications, proc

📌 Regulatory Affairs CMC – Manager/Associate Director/Director (Lima)
🏢 Discover International
📍 Lima