Job Description
A Principal Scientist: Global Regulatory Affairs (CMC) is required on a PERMANENT basis by CareerWise Recruitment for our Limerick based start-up Biopharmaceutical Client. 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. 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 by a demonstrated ability to establish and/or to promote / refine key regulatory CMC positions and to effectively influence development, manufacturing and GRA leadership on these positions.
Role of this position
1. Will oversee the preparation and documentation of specified regulatory submissions
2. Provide regulatory leadership and direction for products listed as primary responsibilities
3. Will 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
4. Manage submission timelines, monitor approval status and communicate change status to interested personnel in a timely manner
5. Will have a good understanding of existing and emerging pharmaceutical & biotech-related regulations
6. Provides the necessary CM&C commitment information to site personnel
7. Ensure compliance of GMP documents to regulatory commitments and provides support for batch release process (review/approval deviations, status of approval of change etc.)
8. Review and/or approval of regulatory changes, regulatory deviations, proposals for reprocessing, validation and stability protocols
9. Will participate in Global Regulatory Affairs-CMC group to share best practices and develop internal guidelines/initiatives
10. Will participate, where applicable, in industry association meetings (e.g. PCI) and Client groups to benchmark and influence revisions to guidance
11. Will interpret new/revised guidance documents and evaluates impact for site. Provides comments on draft guidance's, as applicable
12. Will provide training to site personnel regarding product registration requirements and applicable regulations and guidelines
JOB REQUIREMENTS
13. Level 8 Bachelor's degree in sciences discipline (e.g. chemistry, biology, biochemistry or pharmacy or related scientific discipline) required.
14. 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.
15. Pharmaceutical industry experience in a CMC-related field (5-7 years) will also be considered.
16. Strong knowledge of regulatory and compliance guidelines within pharmaceutical / biopharmaceutical manufacturing
17. Good attention to detail and demonstrated effective teamwork skills
18. Proven ability to effectively influence within and beyond the organization
19. Can demonstrate leadership capabilities, particularly with the view to influencing and developing in an international matrix environment, hereby demonstrating a wider business perspective.
20. Will facilitate a collaborative environment with all internal and external stakeholders.
21. 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 to increase their awareness.
22. Lead and/or contribute corporate improvement efforts at local and international level.