- 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 in international Manufacturing Site Regulatory Group to share best practices and develop internal guidelines/initiatives
- Will participate, where applicable, in industry association meetings (e.g. PCI) and internal 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 Provides comments on draft guidance's, as applicable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
- Minimum of degree, ideally an advanced degree (MS or PhD preferred), in related biological and life science field
- 3+ years (associate to mid-level) relevant regulatory affairs experience in the pharmaceutical/biopharmaceutical industry
- Solid 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.
- Will 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 to increase their awareness.
- Lead and/or contribute corporate improvement efforts at local and international level.
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
Fastnet - The Talent Group
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The Life Science Specialists