About You

This individual will provide CMC regulatory expertise and oversight of CMC regulatory submissions. This individual will ensure the planning, development, and finalization of high-quality CMC documentation designed to meet regulatory requirements.

This individual is the responsible subject-matter expert in the field of Regulatory CMC with experience filing a successful NDA/MAA for a new chemical entity and have a direct influence on the decision-making processes within the scope of CMC-related activities.

The successful candidate is expected to develop strong relationships with various departments.

Responsibilities

• Collaborate and partner closely with CMC colleagues to develop CMC global regulatory submission strategies, complete content review, assure compliance with regulatory standards and health authority guidance while maintaining submission timelines to meet business objectives
• Plan and track the completion of CMC content for IND/CTA submissions while ensuring company template content conforms with regulatory requirements
• Coordinate responses to CMC information requests from health authorities
• Ensure that appropriate documented quality control (QC) checks are performed for CMC documents before health authority submission and respond to findings, and recommend process improvements as needed
• Collaborate with CMC Team and Quality to ensure regulatory conformance of technical documentation, including technical transfer protocols, validation protocols, and technical reports, manufacturing and packaging/labeling information
• Ensure communication and alignment on CMC regulatory strategy through partnership and communication with internal key stakeholders
• Proactively identify potential risks to programs and contribute to solutions to keep assigned programs on track while maintaining high-quality
• Ensure that CMC-related changes are reported to authorities per regulatory requirements
• Responsible for regulatory impact assessments for CMC change control
• Lead preparation for health authority meetings with CMC focus and participate in multidisciplinary efforts to prepare CMC updates to regulatory documents including, Investigator Brochures, Annual Reports, and briefing documents for health authority meetings
• Work closely with the regulatory operations group to ensure proper archival of CMC- related Health Authority correspondence, regulatory commitments and Agency reporting obligations for the organization
• Maintain knowledge of current and emerging CMC regulatory requirements, guidelines, and best practices, and effectively communicate relevant topics to colleagues
• Oversee responsibilities for department staff and vendors as agreed with the manager

Qualifications

• 15+ years of experience with a Bachelor's degree, or 12+ years with a post graduate degree
• Experience in Biologics
• Successful experience leading Regulatory CMC activities for multiple regulatory filings in pre-and post-approval settings, including experience filing an NDA/MAA for an NCE
• Excellent oral and written communication skills with proven ability to analyze and organize information logically
• Thorough knowledge of drug development, health authority regulations and guidelines, CMC and Quality documentation standards, with the ability to apply knowledge to guide the delivery of regulatory documents efficiently
• Strong leadership and project management skills, ability to work independently, multi-task, and work effectively under pressure
• Excellent interpersonal, active listening, and influencing skills
• Strong collaboration, teamwork, organizational skills, and attention to detail
• Prior management experience preferred