Regulatory Affairs Scientist

CareerWise Recruitment

Cork

A PERMANENT Regulatory Affairs Scientist is required by CareerWise Recruitment for our Cork based Biopharmaceutical client. The purpose of the Regulatory Affairs Scientist role is to provide strategic, tactical and operational direction to expedite CMC development of the company's 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. THE ROLE: * 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 company Global Regulatory Affairs-CMC group to share best practices and develop internal guidelines/initiatives. * Will participate, where applicable, in industry association meetings (e.g. PCI) and company groups to benchmark and influence revisions to guidance. * Will interpret new/revised guidance documents and evaluates impact for site. Provides comments on draft guidance, as applicable. * Will 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) required. * 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. OR. * Pharmaceutical industry experience in a CMC-related field (5-7 years) will also be considered. Additional Skills/Preferences: * Strong knowledge of regulatory and compliance guidelines within pharmaceutical / biopharmaceutical manufacturing. Please call Aisling O'Hagan-Yil today for further information on 021- 2427410 or email: aohagan-yil@careerwise.ie. CareerWise Recruitment (In Search of Excellence. Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin. By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent.

569 days ago