CMC Regulatory Sciences Specialist

Role Summary

We are seeking a highly motivated CMC Regulatory Sciences Specialist (Commercial Submissions) to join our dynamic CMC Regulatory Sciences team. The successful candidate will play a critical role in overseeing the Chemistry, Manufacturing, and Controls (CMC) aspects of commercial submissions, ensuring compliance with global regulatory standards. Routine activities include dossier development for initial global marketing applications, commercial post-approval updates, and other regulatory submissions. Strong technical writing skills are essential for effectively communicating complex scientific information.

Responsibilities

• Drafting and reviewing global CMC documents and sections for a variety of commercial biopharmaceutical regulatory submissions, ensuring that all submissions are complete, accurate and meet relevant requirements.
• Handling and coordinating the authoring, review and finalization of CMC documents and responses to CMC-related inquiries from regulatory agencies, in accordance with submission timelines, keeping all team members, including third-party partners, advised of progress.
• Collaborating and developing excellent relationships with functional area and cross functional teams, contract manufacturing organizations, and global Regulatory partners.
• Applying in-depth understanding of regulatory guidance and regulations, as well as industry and government agency standard processes and trends to written work and strategy.
• Reviewing relevant CMC documents and reports for completeness, accuracy and compliance with regulations and regulatory guidance.
• Proactively identifying risks and contributing to the development of appropriate strategies to mitigate them.
• Assisting in preparation for meetings with global regulatory authorities.
• Contributing to developing CMC regulatory strategy.

Qualifications

• Excellent written and verbal communication skills.
• Ability to work independently, prioritize, coordinate and complete multiple projects within deadline while maintaining a level of attention to detail.
• Strong skills in planning, critical thinking and problem-solving.
• Knowledge of drug development regulations and guidelines (i.e., FDA regulations and ICH guidelines) as well as an understanding of CGMPs (Current Good Manufacturing Practices). Preferred, but not required.

Education

• BS/BA degree in a scientific discipline is required. Advanced degree preferred.

Experience

• CMC Regulatory Sciences Specialist: 2 years of relevant experience in a biopharmaceutical and/or CMC regulatory or industry setting
• Senior CMC Regulatory Sciences Specialist: 5 years of relevant experience in a biopharmaceutical and/or CMC regulatory or industry setting
• May consider equivalent combination of education and experience.
• Level is determined based on qualifications relevant to the role.