Job Description
A Principal Scientist: Global Regulatory Affairs (CMC) is required on a permanent basis. The purpose of the role is to provide strategic, tactical, and operational direction to expedite CMC development of Client portfolio and technical agenda by supporting global clinical trial, market registration submissions, and post-approval submissions.
Key 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.
* 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 necessary CM&C commitment information to site personnel.
* Ensure compliance of GMP documents to regulatory commitments and provide support for batch release process.
* Review and/or approval of 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 and Client groups to benchmark and influence revisions to guidance.
* Interpret new/revised guidance documents and evaluate impact for site. Provide comments on draft guidance's, as applicable.
* Provide training to site personnel regarding product registration requirements and applicable regulations and guidelines.
Requirements:
* Bachelor's degree in sciences discipline (e.g. chemistry, biology, biochemistry or pharmacy or related scientific discipline).
* 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.
* 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.
* Demonstrate leadership capabilities, particularly with the view to influencing and developing in an international matrix environment.
* Facilitate a collaborative environment with all internal and external stakeholders.
* Stay abreast with current technical and regulatory trends and continually develop knowledge by attending training courses, conferences or association meetings and share such information with other members of the group or company.