USA-Regulatory Affairs Specialist II (Clinical)
: Job Details :

Job Title: Regulatory Affairs Specialist II Location: Swiftwater, PADuration: 06+ Months (Possible Extension) Job DescriptionThe Regulatory CMC Specialist will work closely with the Regulatory Site Office, Manufacturing and Supply teams, and CMC colleagues on Vaccines site-based projects to achieve submissions and approvals in key markets and to maintain regulatory compliance for License registrations in existing markets.MissionThe Regulatory CMC Specialist in Regulatory Site Office supports regulatory compliance for marketed products by means of compliant and timely handling of regulatory activities at Swiftwater. The incumbent manages regulatory activities linked to change controls for the site, including the update of CMC files. The incumbent is accountable for product license maintenance and site registrations. The incumbent also ensures the role of regulatory expert for regulatory topics and projects at the Swiftwater and Pearl River sites.Duties and Responsibilities:The Regulatory CMC Specialist may have responsibility for one or more products or activities in the RSO Vaccines group.The Regulatory CMC Specialist, manages authoring of CMC regulatory documents (modules 1.2, 2.3 and 3) to support Marketing Authorizations and other documentation that support site registrations, specific country documentation, and Annual reports.The Regulatory CMC Specialist prepares responses to Health Authority questions related to CMC from Regulatory affiliates with the contribution of site experts.The Regulatory CMC Specialist may participate in transversal activities by serving as Regulatory interface between M&S, MSAT and GRA.The Regulatory CMC Specialist will ensure Regulatory compliance by providing support to batch release by checking submission/approvals, ensuring permanent regulatory/license compliance and reviewing and approving site documents (e.g. Standard Operating Procedures).The Regulatory CMC Specialist may represent RSO on M&S and MSAT project teams when product or valence-related regulatory site expertise is required.Key AccountabilityRegulatory Compliance: Supports batch release by following submission and approval to ensure the product regulatory compliance on his/her sites(s) Response to agency lot release questions Ensures that the CMC dossier is in line with manufacturing and control procedures on site(s) and with dossiers approved by Health Authorities Prepares and provides Regulatory documentation required for site registration and renewal activitiesCMC Documentation Management: Writes and approves CMC regulatory documents/dossiers to be dispatched to regulatory affairs functions for submissions Coordinates CMC writing performed by another entity (internal or external) Optimizes the content of CMC dossiers to facilitate the management of future changes Prepares response to questions from Health Authorities with contribution of site experts Supports Marketing Authorizations worldwide (territory extensions, renewals, site registrations and transfers, etc.) by writing the corresponding CMC documents/dossiers and collecting GMP related documents from the site(s) Consolidates regulatory activities in a planning toolTransversal Activities: Contributes to Regulatory intelligence on the specific field of competencies and communicates the appropriate information to the site Contributes to the implementation of the appropriate company tools to manage activities Contributes to site inspections and audits Attends and contributes Regulatory site expertise to designated Projects, Committees, Team meetings May contribute to Critical Process Analysis and Testing Strategies Organizational Reporting and Communication:Responsible for reporting on the progress and specific issues pertaining to project/product responsibilities. Planning/Coordination: As per the assignment, the incumbent will support or work jointly with other Regualtory Affairs functions, and project managers for the planning and coordination of regulatory CMC activites relating to projects/products from intiation to approval, which include:Detailed plan prioritization and coordination of activities with Liason/Franchise groupsSupporting CMC related regulatory objectives and target datesProviding timelines for critical CMC regulatory activities to be incorporated into the project plan Regulatory Guidance: Responsible for contributing to site regulatory advice and guidance to Project/Product Team members and other functional areas on regulatory matters. This could include:Providing information from regulatory requirements documents and other appropriate guidance documents. Personal Development / Training: Responsible for staying up-to-date on regulatory guidances and technical/scientific developments. Maintaining 100% compliance on all assigned and alpplicale training on a regular basis.Knowledge, Skills & Competencies Strong authoring skills of CMC documentation and Health Authority responses Ability to resolve strategic technical and regulatory issues Should demonstrate initiative, analytical thinking and works independently Ability to work well with cross functional teams, and good communication skills with internal and external stakeholders Experience working with a Health Authority is helpful but not essential Knowledge of global regulations/guidelines, key Health Authority/Industry Guidance and trends are helpfulQualificationsEducation / Experience: Bachelors degree in Biological Sciences with 2+ years Regulatory Affairs experience OR Masters degree in Regulatory Affairs/Quality Assurance or an appropriate combination of other relevant industry experience e.g., Quality and/or Manufacturing Requires knowledge and understanding of CMC topics, as well as North American, European and International regulations/guidelines Ability to manage multiple priorities efficiently Experience working on Project teams Demonstrated knowledge of microbiology, immunology, virology or bacteriology Excellent skills in communication, writing and teamwork