Director Regulatory CMC

Job Description

Job Description

The Director, Regulatory CMC will lead the development and execution of global Chemistry, Manufacturing, and Controls (CMC) regulatory strategies to support the development, registration, and lifecycle management of biologic oncology products. This role will serve as the primary CMC regulatory interface with internal teams and global health authorities, ensuring compliance with evolving regulatory requirements.

Key Responsibilities

• Develop and implement global CMC regulatory strategies for biologics products from early development through post-approval.
• Oversee the preparation, review, and submission of high-quality CMC sections of regulatory filings (INDs, IMPDs, BLAs, MAAs, amendments, supplements) in compliance with global regulatory requirements.
• Serve as the primary CMC regulatory representative on cross-functional project teams, including Clinical, Quality, Manufacturing, and Program Management, to ensure integrated development strategies.
• Provide strategic input into process development, analytical method validation, comparability protocols, and control strategies to support late-stage development and commercial readiness.
• Lead regulatory interactions with global health authorities (e.g., FDA, EMA, MHRA), including the preparation of briefing documents, responses to information requests, and participation in meetings.
• Anticipate and proactively manage CMC regulatory risks, including gap assessments and mitigation strategies for late-phase and pre-commercial programs.
• Collaborate with internal and external manufacturing partners (CDMOs / CMOs) to ensure regulatory compliance and readiness for inspections and submissions.
• Monitor and analyze regulatory agency activities regarding CMC development and assess potential impact on development programs and stay abreast of the regulatory landscape.
• Assume a global view of CMC regulatory strategy and help teams navigate regional requirements and the potential interplay between key regulatory agencies.
• Support the development and maintenance of regulatory CMC policies, procedures, and best practices to ensure operational excellence and compliance.
• Contribute to regulatory due diligence activities for potential in-licensing or partnership opportunities, particularly in the oncology space.
• Mentor and guide junior regulatory staff, fostering a culture of collaboration, accountability, and continuous improvement.

Qualifications

Company Description

A top 10 pharmaceutical company with an immense amount of growth after releasing their at home COVID diagnostic tests is looking to bring on 200+ Quality Individuals through a massive hiring campaign. In their search for Quality Specialists, the organization is looking for individuals who will be responsible for reviewing and actioning customer complaints, as well as investigation into said complaints.

Job Responsibilities :

Education and Experience :

Company Description

A top 10 pharmaceutical company with an immense amount of growth after releasing their at home COVID diagnostic tests is looking to bring on 200+ Quality Individuals through a massive hiring campaign. In their search for Quality Specialists, the organization is looking for individuals who will be responsible for reviewing and actioning customer complaints, as well as investigation into said complaints.\r\nJob Responsibilities : \r\n