Job Title: Principal Scientist- Global Regulatory Affairs-CMC
We are seeking a highly experienced and skilled Principal Scientist to join our team in Cork, Ireland. This is a permanent role with hybrid working opportunities.
About the Role:
This position provides strategic, tactical, and operational direction for the development of our organisation's portfolio and technical agenda. The successful candidate will be responsible for supporting global clinical trial, market registration submissions, and post-approval submissions.
Responsibilities:
* Oversee the preparation of regulatory submissions and provide leadership and direction for products with primary responsibilities.
* Develop, plan, and execute regulatory strategies and priorities through effective partnerships with other departments, including TS/MS (process and technology transfer), manufacturing, quality control, and quality assurance.
* Manage submission timelines, monitor approval status, and communicate changes to relevant personnel in a timely manner.
* Provide CM&C commitment information to site personnel and ensure compliance with GMP documents and regulatory commitments.
* Review and approve regulatory changes, deviations, proposals for reprocessing, validation, and stability protocols.
* Participate in the Global Regulatory Affairs-CMC group to share best practices and develop internal guidelines/initiatives.
* Represent the company in industry association meetings and groups to benchmark and influence revisions to guidances.
* Interpret new/revised guidance documents and evaluate their impact on the site.
Requirements:
* Bachelor's degree in a scientific discipline, such as chemistry, biology, biochemistry, or pharmacy, or a related scientific discipline.
* Prior experience in Regulatory CMC, with 3-7 years of experience or equivalent combination of technical and regulatory guidance knowledge and experience preparing regulatory submission content in a technical function.
* Strong knowledge of regulatory and compliance guidelines within pharmaceutical/biopharmaceutical manufacturing.
* Excellent attention to detail and demonstrated effective teamwork skills.
* Proven ability to effectively influence within and beyond the organisation.
Skills:
* Regulatory Affairs CMC
* Regulatory Affairs
* Regulatory Associate