About this role
<style type="text/css"> table.MiTabla { max-width: 1020px;!important </style> <table border="0" cellspacing="0" cellpadding="0"> <tbody> <tr> <td><img src="https://staticweb.grifols.com/documents/675849/2554718/SSFF_06_GPO.jpg/a5d80af4-bb13-a8cd-d567-ea1e87192f07?t=1636640424362" alt="" align="top/"></td> </tr> <tr> <td> <p style="text-align:justify">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.</p> </td> </tr> <tr> <td><img src="https://staticweb.grifols.com/documents/675849/2554709/SuccesFactors_1020x93_jobposting_line_test.png/e2cffc87-a707-9e08-b5ef-081cae1f1ecf?t=1636640341637" width="100%"></td> </tr> </tbody> </table><p><span style="font-size:12.0pt"><span style="font-family:'Arial Narrow', sans-serif"><strong><u><span style="font-size:11.0pt"><span style="font-family:Calibri, sans-serif">Summary:</span></span></u></strong></span></span></p> <p><span style="font-size:12.0pt"><span style="font-family:'Arial Narrow', sans-serif"><span style="font-size:11.0pt"><span style="font-family:Calibri, sans-serif">Plasma Regulatory Affairs oversees the licensing, surveillance, and other regulatory activities associated with Source Plasma collection within the United States of America, Canada and Rest of World (ROW). This includes activities associated with US Food and Drug Administration (FDA) licensure and registration (biologics (BLA), medical device), Health Canada licensing, Clinical Laboratory Improvement Amendments (CLIA) activities, Plasma Protein Therapeutics Association (PPTA) membership and certification, COLA accreditation, state/province requirements and ROW licensing activities as applicable. </span></span></span></span></p> <p><span style="font-size:12.0pt"><span style="font-family:'Arial Narrow', sans-serif"><span style="font-size:11.0pt"><span style="font-family:Calibri, sans-serif">The Plasma Regulatory Affairs Associate will monitor and perform administrative activities for existing licenses in compliance with US FDA, CLIA, PPTA and COLA requirements to meet business objectives.</span></span></span></span></p> <p> </p> <p><span style="font-size:12.0pt"><span style="font-family:'Arial Narrow', sans-serif"><strong><u><span style="font-size:11.0pt"><span style="font-family:Calibri, sans-serif">Primary Responsibilities:</span></span></u></strong></span></span></p> <ul> <li><span style="font-size:12.0pt"><span style="font-family:'Arial Narrow', sans-serif"><span style="font-size:11.0pt"><span style="font-family:Calibri, sans-serif">Accurately prepare regulatory applications required by federal and other regulatory authorities, as well as industry affiliates for review prior to application submission.</span></span></span></span></li> <li><span style="font-size:12.0pt"><span style="font-family:'Arial Narrow', sans-serif"><span style="font-size:11.0pt"><span style="font-family:Calibri, sans-serif">Research internal documents, complete applications, and forms; prepare cover letters and summaries; assemble and format applications in a manner to facilitate the review process. </span></span></span></span></li> <li><span style="font-size:12.0pt"><span style="font-family:'Arial Narrow', sans-serif"><span style="font-size:11.0pt"><span style="font-family:Calibri, sans-serif">Submit and monitor application submission for timely review and acceptance with the ability to respond to regulatory agency inquiries.</span></span></span></span></li> <li><span style="font-size:12.0pt"><span style="font-family:'Arial Narrow', sans-serif"><span style="font-size:11.0pt"><span style="font-family:Calibri, sans-serif">Provide updates to management on the status of applications.</span></span></span></span></li> <li><span style="font-size:12.0pt"><span style="font-family:'Arial Narrow', sans-serif"><span style="font-size:11.0pt"><span style="font-family:Calibri, sans-serif">Escalate to management urgent and time-sensitive matters that impact regulatory compliance.</span></span></span></span></li> <li><span style="font-size:12.0pt"><span style="font-family:'Arial Narrow', sans-serif"><span style="font-size:11.0pt"><span style="font-family:Calibri, sans-serif">Maintain files contemporaneously for transparency and timelines. </span></span></span></span></li> <li><span style="font-size:12.0pt"><span style="font-family:'Arial Narrow', sans-serif"><span style="font-size:11.0pt"><span style="font-family:Calibri, sans-serif">Maintain applicable shared mailboxes, dashboards and accounts related to administrative licensing activities.</span></span></span></span></li> <li><span style="font-size:12.0pt"><span style="font-family:'Arial Narrow', sans-serif"><span style="font-size:11.0pt"><span style="font-family:Calibri, sans-serif">Archive and distribute applications electronically and in hardcopy.</span></span></span></span></li> <li><span style="font-size:12.0pt"><span style="font-family:'Arial Narrow', sans-serif"><span style="font-size:11.0pt"><span style="font-family:Calibri, sans-serif">Record the details of pertinent conversations and/or written interactions with a regulatory authority, when applicable.</span></span></span></span></li> <li><span style="font-size:12.0pt"><span style="font-family:'Arial Narrow', sans-serif"><span style="font-size:11.0pt"><span style="font-family:Calibri, sans-serif">Educate and inform internal customers at the corporate office and at the plasmapheresis centers regarding regulatory requirements as it pertains to licensing activities.</span></span></span></span></li> <li><span style="font-size:12.0pt"><span style="font-family:'Arial Narrow', sans-serif"><span style="font-size:11.0pt"><span style="font-family:Calibri, sans-serif">Provide registration and licensing documentation to stakeholders in a timely manner.</span></span></span></span></li> <li><span style="font-size:12.0pt"><span style="font-family:'Arial Narrow', sans-serif"><span style="font-size:11.0pt"><span style="font-family:Calibri, sans-serif">Assist with evaluation of regulatory changes for impact to the business.</span></span></span></span></li> <li><span style="font-size:12.0pt"><span style="font-family:'Arial Narrow', sans-serif"><span style="font-size:11.0pt"><span style="font-family:Calibri, sans-serif">Process and track all invoices to ensure prompt payment associated with licensing activities.</span></span></span></span></li> </ul> <p> </p> <p><span style="font-size:12.0pt"><span style="font-family:'Arial Narrow', sans-serif"><strong><u><span style="font-size:11.0pt"><span style="font-family:Calibri, sans-serif">Additional Responsibilities:</span></span></u></strong></span></span></p> <ul> <li><span style="font-size:12.0pt"><span style="font-family:'Arial Narrow', sans-serif"><span style="font-size:11.0pt"><span style="font-family:Calibri, sans-serif">Exhibits professional behavior with internal/external business associates, reflecting positively on the company.</span></span></span></span></li> <li><span style="font-size:12.0pt"><span style="font-family:'Arial Narrow', sans-serif"><span style="font-size:11.0pt"><span style="font-family:Calibri, sans-serif">Understands the quality consequences of improper job performance and is aware of potential compliance defects in their area of responsibility.</span></span></span></span></li> <li><span style="font-size:12.0pt"><span style="font-family:'Arial Narrow', sans-serif"><span style="font-size:11.0pt"><span style="font-family:Calibri, sans-serif">Interface with various levels and groups throughout the organization. </span></span></span></span></li> <li><span style="font-size:12.0pt"><span style="font-family:'Arial Narrow', sans-serif"><span style="font-size:11.0pt"><span style="font-family:Calibri, sans-serif">Manage multiple tasks with competing demands and deadlines. </span></span></span></span></li> <li><span style="font-size:12.0pt"><span style="font-family:'Arial Narrow', sans-serif"><span style="font-size:11.0pt"><span style="font-family:Calibri, sans-serif">Assist with department related projects, goals and/or objectives.</span></span></span></span></li> <li><span style="font-size:12.0pt"><span style="font-family:'Arial Narrow', sans-serif"><span style="font-size:11.0pt"><span style="font-family:Calibri, sans-serif">Perform other duties as required.</span></span></span></span></li> </ul> <p> </p> <p><span style="font-size:12.0pt"><span style="font-family:'Arial Narrow', sans-serif"><strong><u><span style="font-size:11.0pt"><span style="font-family:Calibri, sans-serif">Knowledge, Skills, and Abilities:</span></span></u></strong></span></span></p> <ul> <li><span style="font-size:12.0pt"><span style="font-family:'Arial Narrow', sans-serif"><span style="font-size:11.0pt"><span style="font-family:Calibri, sans-serif">Exhibits professional behavior with internal/external business associates, reflecting positively on the company.</span></span></span></span></li> <li><span style="font-size:12.0pt"><span style="font-family:'Arial Narrow', sans-serif"><span style="font-size:11.0pt"><span style="font-family:Calibri, sans-serif">Understands the quality consequences of improper job performance and is aware of potential compliance defects in their area of responsibility.</span></span></span></span></li> <li><span style="font-size:12.0pt"><span style="font-family:'Arial Narrow', sans-serif"><span style="font-size:11.0pt"><span style="font-family:Calibri, sans-serif">Interface with various levels and groups throughout the organization. </span></span></span></span></li> <li><span style="font-size:12.0pt"><span style="font-family:'Arial Narrow', sans-serif"><span style="font-size:11.0pt"><span style="font-family:Calibri, sans-serif">Manage multiple tasks with competing demands and deadlines. </span></span></span></span></li> <li><span style="font-size:12.0pt"><span style="font-family:'Arial Narrow', sans-serif"><span style="font-size:11.0pt"><span style="font-family:Calibri, sans-serif">Assist with department related projects, goals and/or objectives. </span></span></span></span></li> <li><span style="font-size:12.0pt"><span style="font-family:'Arial Narrow', sans-serif"><span style="font-size:11.0pt"><span style="font-family:Calibri, sans-serif">Perform other duties as required. </span></span></span></span></li> <li><span style="font-size:12.0pt"><span style="font-family:'Arial Narrow', sans-serif"><span style="font-size:11.0pt"><span style="font-family:Calibri, sans-serif">Experience with Microsoft Office.</span></span></span></span></li> <li><span style="font-size:12.0pt"><span style="font-family:'Arial Narrow', sans-serif"><span style="font-size:11.0pt"><span style="font-family:Calibri, sans-serif">Experience with Adobe PDF.</span></span></span></span></li> <li><span style="font-size:12.0pt"><span style="font-family:'Arial Narrow', sans-serif"><span style="font-size:11.0pt"><span style="font-family:Calibri, sans-serif">Experience in plasma collection, pharmaceutical industry, or a regulated field.</span></span></span></span></li> </ul> <p> </p> <p><span style="font-size:12.0pt"><span style="font-family:'Arial Narrow', sans-serif"><strong><u><span style="font-size:11.0pt"><span style="font-family:Calibri, sans-serif">Education and Experience:</span></span></u></strong></span></span></p> <ul> <li><span style="font-size:12.0pt"><span style="font-family:'Arial Narrow', sans-serif"><span style="font-size:11.0pt"><span style="font-family:Calibri, sans-serif">Bachelor's Degree in a scientific discipline (e.g., Pharmacy, Chemistry, Biology).</span></span></span></span></li> <li><span style="font-size:12.0pt"><span style="font-family:'Arial Narrow', sans-serif"><span style="font-size:11.0pt"><span style="font-family:Calibri, sans-serif">Preferred two (2) years related technical and/or regulatory experience in pharmaceutical or blood industry. </span></span></span></span></li> <li><span style="font-size:12.0pt"><span style="font-family:'Arial Narrow', sans-serif"><span style="font-size:11.0pt"><span style="font-family:Calibri, sans-serif">Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Master’s degree with 2 years of experience. </span></span></span></span></li> </ul> <p> </p> <p><span style="font-size:12.0pt"><span style="font-family:'Arial Narrow', sans-serif"><strong><u><span style="font-size:11.0pt"><span style="font-family:Calibri, sans-serif">Occupational Demands:</span></span></u></strong></span></span></p> <p><span style="font-size:12.0pt"><span style="font-family:'Arial Narrow', sans-serif"><span style="font-size:11.0pt"><span style="font-family:Calibri, sans-serif">Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Reliance on oral or written instructions and plans work schedules to meet goals. Frequently interacts with others, relates sensitive information to diverse groups. </span></span></span></span></p> <p>#Biomatusa</p> <p>#App</p><p style="margin-bottom:11.0px"> </p> <p style="margin-bottom:11.0px"><span style="font-size:11.0pt"><span style="font-family:Calibri, sans-serif">Third Party Agency and Recruiter Notice:</span></span></p> <p style="margin-bottom:11.0px"><span style="font-size:11.0pt"><span style="font-family:Calibri, sans-serif">Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.</span></span></p> <p style="margin-bottom:11.0px"> </p> <p style="margin-bottom:11.0px"><strong><span style="font-size:11.0pt"><span style="font-family:Calibri, sans-serif">Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws.</span></span></strong></p> <p> </p> <p><img src="https://staticweb.grifols.com/documents/675849/2554709/SuccesFactors_1020x93_jobposting_line_test.png/e2cffc87-a707-9e08-b5ef-081cae1f1ecf?t=1636640341637" width="100%"></p> <p><strong>Location: NORTH AMERICA : USA : NC-RTP:USNC0003 - RTP NC-Research Building 85</strong></p> <p> </p> <p><a href="https://www.grifols.com/en/what-we-do" target="_blank" rel="noopener">Learn more about Grifols</a></p> <p> </p>