Description
My client is one of the largest pharmaceutical companies in the world that has been consistently ranked as one of the best companies in the world to work for. The Company supports the development, manufacture and supply of many medicines in their portfolio. They are committed to bringing life changing medicines to those who need them.The Regulatory Affairs Scientist job will involve:
- Will oversee the preparation and documentation of specified regulatory submissions
- Provide regulatory leadership and direction for products listed as primary responsibilities
- 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
- Manage submission timelines, monitor approval status and communicate change status to interested personnel in a timely manner
- Will have a good understanding of existing and emerging pharmaceutical & biotech-related regulations
- Provides the necessary CM&C commitment information to site personnel
- Ensure compliance of GMP documents to regulatory commitments and provides support for batch release process (review/approval deviations, status of approval of change etc.)
- Review and/or approval of regulatory changes, regulatory deviations, proposals for reprocessing, validation and stability protocols
- Will participate, where applicable, in industry association meetings and groups to benchmark and influence revisions to guidance's
- Will interpret new/revised guidance documents and evaluates impact for site. Provides comments on draft guidance's, as applicable
- Will provide training to site personnel regarding product registration requirements and applicable regulations and guidelines.
Experience Required:
- Degree in Biological Sciences, Life Science or related discipline.
- Advanced degree preferred
- Min 5 Years' relevant regulatory affairs experience in the pharmaceutical/bio-pharmaceutical industry.
- Experience with regulatory submissions.
The Ideal Person:
- Substantial post-qualification experience in either a pharmaceutical or biotech setting, previous experience with regulatory submissions is an advantage.
- Strong knowledge of regulatory and compliance guidelines within pharmaceutical / biopharmaceutical manufacturing.
- Proven ability to effectively influence within and beyond the organization.
- Can demonstrate leadership capabilities, particularly with the view to influencing and developing in an international matrix environment, hereby demonstrating a wider business perspective.
Package:
An excellent salary depending on experience is on offer along with an attractive benefits package that can be discussed following application.
This is a permanent role and is placed in Cork. Interviews will commence immediately so if you are interested in this Regulatory Affairs Scientist job please send an updated CV to Amanda Murphy for consideration or ring me on to discuss further