Sr. Regulatory Affairs Specialist II/Manager

Sr. Regulatory Affairs Specialist II/Manager Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. Implement worldwide regulatory product registration strategies, prepare complex registration dossiers, establish and maintain tracking of product registrations to determine what products can be shipped to intended markets in accordance with business plan with a specific focus on labeling, labeling requirements, and implementation. Coordinate and submit all regulatory documentation for establishment of new / changed local market authorization holders and distributors. Primary responsibilities include: acting as Regulatory Affairs authority for key product registrations with a main focus in labeling and labeling related activities; analyzing and determining worldwide product registration requirements for specific assigned products and regions; preparing complex registration dossiers, local application forms; negotiating documentation required for worldwide markets; preparing responses to regulatory agency inquiries; coordinating with local authorities and Quality standards and controls required for product registration testing; representing the regulatory function in communication with outside companies, customers and regulatory authorities; collaborating with all disciplines to assure appropriate testing and documentation are generated for regulatory submissions and routine import documentation; coordinating and interacting with domestic and international regulatory counterparts to obtain input regarding regulatory considerations and decisions to formulate regulatory strategy for changes to products/facilities/equipment with an impact on product labeling; requesting and obtaining all required FDA export documentation required for registration and routine product shipments; evaluating impact of new labeling regulatory requirements as well as evaluate changes to existing product labeling on assigned projects and products and inform other departments as necessary; maintaining worldwide product registration status and distributing routine updates to commercial, sales and Quality to determine where registered products can be marketed; mentoring and supporting the professional development of staff; and performing other duties as required. Knowledge, skills, and abilities include: ability to prioritize and initiate contacts essential to labeling submission preparation; ability to work independently and initiate contacts essential to create labeling components for submission preparation while ensuring technical information is accurate; knowledge of product and labeling history to maintain consistency within a product line and within the product portfolio labeling; ability to clearly communicate verbally and in writing with internal and external contacts; ability to work with management of other Grifols departments to achieve common business goals as well as regulatory objectives; ability to review a document, including labeling, in detail to ensure accuracy based on regulatory requirements; ability to effectively use Microsoft Office to create, edit, and format documents; ability to work with other computer systems for filing supplements and reports; ability to interpret and effectively communicate regulatory requirements internally as well as to distributors/affiliates with a specific focus in labeling; ability to successfully interact with external contacts; and ability to meet statutory deadlines to ensure compliance, as well as business timelines to accomplish company objectives. Preferred background includes: advanced degree with clinical experience; experience working on global labeling initiatives and submissions; familiarity with electronic labeling systems and regulatory publishing tools; and demonstrated leadership in cross-functional team settings. Minimum requirements: Sr. Specialist II: Bachelor's degree in relevant discipline, or equivalent work experience industry regulatory experience; minimum 5 years of related technical and/or regulatory experience in pharmaceutical industry or an equivalent combination of education and experience; experience with biological products related to but not limited to facilities, validation, environmental monitoring, cGMP manufacturing, QA/QC for biological products, compliance and/or regulatory is required; and excellent written and verbal communication skills. Manager: Bachelor's degree in relevant discipline, or equivalent work experience industry regulatory experience; 6 to 7 years related technical and/or regulatory experience in pharmaceutical industry, or an equivalent combination of education and experience; extensive knowledge of applicable worldwide regulatory product registrations laws and regulations; and excellent verbal and written communication skills.

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