Manager, Global Regulatory CMC

Manager, Global Regulatory CMC
Pennsylvania - United States

Seeking an experienced Manager of Global Regulatory CMC to work closely and collaboratively with the Regulatory CMC Product Lead for a growing group in Philadelphia. This new hire will be responsible for providing support and guidance for all global commercialized products.

Responsibilities

• Manage execution of the following CMC documentation, i.e.: IND/CTA, NDA/BLA, MAA
• Ensure strong CMC regulatory strategy development for specific projects.
• Ensure global regulatory requirements and strategy are understood and communicated by project teams.
• Work closely with Regulatory CMC Product Lead and provide CMC Regulatory expertise within Regulatory and cross-function teams for the assigned biological products.
• Delivery of all regulatory goals and objectives through product development.
• Manage and prioritize multiple complex projects independently
• Ability to identify regulatory risks and potential issues with a strong expertise in the understanding of global regulations and guidance.
• Review and provide regulatory assessments on change controls measures for global impact.
• Develop, manage and maintain the CMC submissions for all global markets while ensuring diligence, objectives are met, all sections thoroughly completed with accurate data in a timely fashion.
• Utilize electronic systems for dossier creation and tracking.
• Experienced within lifecycle management for biologic-specific drugs.
• Work with Regulatory CMC team members on the development, lifecycle management and assessment of the CMC Regulatory strategy for complex projects.
• Interact with global regulatory agencies for CMC submissions and CMC-related issues.

Qualifications

• Bachelor's degree in life sciences or equivalent is required
• At least 3 years of experience in a biotech/pharmaceutical setting within Regulatory CMC

Required Skills

• Biologics experience required
• CMC regulatory documents experience; Authoring skills and experience with Modules 2 and Modules 3 sections
• Regulatory Information Management & Quality Management systems experience
• Clear understanding of regulatory CMC
• Direct experience and knowledge of working with FDA, EMA and ICH guidelines
• Strong knowledge and understanding of US and international regulations (i.e.: cGMP, GCP, GLP, ICH guidance documents) & an expertise with global regulatory submissions and compliance with all Health Authorities, i.e.: US FDA, EMA
• Hands-on experience managing the execution of Regulatory CMC-specific documents (eCTD), i.e.: IND/CTA, NDA/BLA, MAA
• Prior working knowledge with Regulatory Information Management (RIMS) & Quality Management systems with Change Controls and eCTD submissions expertise
• Strong ability to work and manage multiple projects at any given time.
• Ability to work and think strategically within a complex, business critical and high-profile development program.
• Key skills: Excellent communication skills, both written and verbal communication, excellent organizational skills. Professional, proactive demeanor and team player attitude.

If interested in learning more, please contact Bria Gaber at bria.gaber@investigo-us.com or (646) 430-1191 for more information.