Principal Scientist- Global Regulatory Affairs-CMC Purpose: The purpose of the Principal Scientist- Global Regulatory Affairs-CMC role is to provide strategic, tactical, and operational direction to expedite CMC development and technical agenda by supporting global clinical trial, market registration submissions, and post-approval submissions. These activities are accomplished with a strong working knowledge of global regulations, guidelines, and regulatory precedence, coupled with a strong technical knowledge of CMC development and manufacturing processes. To accomplish this purpose, it is necessary for the Regulatory Scientist to develop collegial and mutually productive relationships and demonstrate the ability to establish and promote/refine key regulatory CMC positions and effectively influence development, manufacturing, and GRA leadership on these positions.
Responsibilities: Oversee the preparation and documentation of specified regulatory submissions.Provide regulatory leadership and direction for products listed as primary responsibilities.Develop, plan, and execute appropriate regulatory strategies and priorities through effective partnership with other departments such as TS/MS (process and technology transfer), manufacturing, quality control, and quality assurance.Manage submission timelines, monitor approval status, and communicate change status to interested personnel in a timely manner.Have a good understanding of existing and emerging pharmaceutical & biotech-related regulations.Provide the necessary CM&C commitment information to site personnel.Ensure compliance of GMP documents to regulatory commitments and provide support for batch release process (review/approval deviations, status of approval of change, etc.).Review and/or approve regulatory changes, regulatory deviations, proposals for reprocessing, validation, and stability protocols.Participate in Global Regulatory Affairs-CMC group to share best practices and develop internal guidelines/initiatives.Participate, where applicable, in industry association meetings (e.g., PCI) and groups to benchmark and influence revisions to guidance.Interpret new/revised guidance documents and evaluate impact for site. Provide comments on draft guidance, as applicable.Provide training to site personnel regarding product registration requirements and applicable regulations and guidelines.Minimum Qualification Requirements: Level 8 Bachelor's degree in sciences discipline (e.g., chemistry, biology, biochemistry, or pharmacy or related scientific discipline) required.Prior Regulatory CMC experience (3-7 years) or equivalent combination of technical and regulatory guidance knowledge and experience preparing regulatory submission content in a technical function.Pharmaceutical industry experience in a CMC-related field (5-7 years) will also be considered.Additional Skills/Preferences: The applicant should have:
Strong knowledge of regulatory and compliance guidelines within pharmaceutical/biopharmaceutical manufacturing.Good attention to detail and demonstrated effective teamwork skills.Proven ability to effectively influence within and beyond the organization.
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