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_10_LA.jpg/c7449196-fba0-6bcb-9d0d-f4c5652819f6?t=1636640424647" 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><h1 style="margin:0.0in;font-size:16.0pt;font-family:Calibri, sans-serif;color:#365f91;font-weight:normal;text-align:center"><span style="font-family:tahoma, arial, helvetica, sans-serif;font-size:12.0pt;color:#dd2727"><strong>This position is based out of Vista, CA on a Hybrid Remote schedule.</strong></span></h1> <h1 style="margin:0.0in;font-size:16.0pt;font-family:Calibri, sans-serif;color:#365f91;font-weight:normal"><span style="font-family:tahoma, arial, helvetica, sans-serif"><strong><u><span style="font-size:10.0pt;color:#262626">Summary:</span></u></strong></span></h1> <h1 style="margin:0.0in;font-size:16.0pt;font-family:Calibri, sans-serif;color:#365f91;font-weight:normal"><span style="font-size:10.0pt;font-family:tahoma, arial, helvetica, sans-serif;color:#262626">The Manager, Regulatory Affairs - Licensing, is responsible for the operation of the Regulatory Affairs Department. The position oversees facility licensing and certification activities (i.e., FDA, EU, PPTA IQPP, CLIA/COLA, AAB, State) for all of Grifols BioSupplies Inc, ensuring that licenses and certificates are obtained and renewed within required time frames. In addition, the Manager, Regulatory Affairs, interacts with internal customers at headquarters, laboratories, manufacturing and plasmapheresis centers to ensure that licensing and certification needs are met in support of company objectives and regulatory compliance.</span></h1> <h1 style="margin:0.0in;font-size:16.0pt;font-family:Calibri, sans-serif;color:#365f91;font-weight:normal"> </h1> <h1 style="margin:0.0in;font-size:16.0pt;font-family:Calibri, sans-serif;color:#365f91;font-weight:normal"><span style="font-family:tahoma, arial, helvetica, sans-serif"><strong><u><span style="font-size:10.0pt;color:#262626">Primary Responsibilities:</span></u></strong></span></h1> <ul> <li style="text-indent:-0.25in;font-size:16.0pt;font-family:Calibri, sans-serif;color:#365f91;font-weight:normal"><span style="font-family:tahoma, arial, helvetica, sans-serif"><span style="font-size:10.0pt;color:#262626">·<span style="font-style:normal;font-weight:normal;font-size:7.0pt;line-height:normal"> </span></span><span style="font-size:10.0pt;color:#262626">Responsible for the operation of the Regulatory Affairs Department</span></span></li> <li style="text-indent:-0.25in;font-size:16.0pt;font-family:Calibri, sans-serif;color:#365f91;font-weight:normal"><span style="font-family:tahoma, arial, helvetica, sans-serif"><span style="font-size:10.0pt;color:#262626">·<span style="font-style:normal;font-weight:normal;font-size:7.0pt;line-height:normal"> </span></span><span style="font-size:10.0pt;color:#262626">Responsible for management of Customer Complaints, Supplier Corrective Action Requests (SCAR), Quality Agreements, Supplier Quality, including customer questionnaires and feedback. </span></span></li> <li style="text-indent:-0.25in;font-size:16.0pt;font-family:Calibri, sans-serif;color:#365f91;font-weight:normal"><span style="font-family:tahoma, arial, helvetica, sans-serif"><span style="font-size:10.0pt;color:#262626">·<span style="font-style:normal;font-weight:normal;font-size:7.0pt;line-height:normal"> </span></span><span style="font-size:10.0pt;color:#262626">Interact and support the control of Customer Specifications</span></span></li> <li style="text-indent:-0.25in;font-size:16.0pt;font-family:Calibri, sans-serif;color:#365f91;font-weight:normal"><span style="font-family:tahoma, arial, helvetica, sans-serif"><span style="font-size:10.0pt;color:#262626">·<span style="font-style:normal;font-weight:normal;font-size:7.0pt;line-height:normal"> </span></span><span style="font-size:10.0pt;color:#262626">Assign work, monitor progress and quality of work so that work is equitably and appropriately assigned and deadlines are met with high quality work</span></span></li> <li style="text-indent:-0.25in;font-size:16.0pt;font-family:Calibri, sans-serif;color:#365f91;font-weight:normal"><span style="font-family:tahoma, arial, helvetica, sans-serif"><span style="font-size:10.0pt;color:#262626">·<span style="font-style:normal;font-weight:normal;font-size:7.0pt;line-height:normal"> </span></span><span style="font-size:10.0pt;color:#262626">Oversee facility licensing and certification (i.e., FDA, EU, PPTA IQPP, CLIA/COLA, AAB, ISO, State) activities for all Grifols plasma companies, ensuring that licenses and certificates, as applicable, are obtained and renewed within required time frames </span></span></li> <li style="text-indent:-0.25in;font-size:16.0pt;font-family:Calibri, sans-serif;color:#365f91;font-weight:normal"><span style="font-family:tahoma, arial, helvetica, sans-serif"><span style="font-size:10.0pt;color:#262626">·<span style="font-style:normal;font-weight:normal;font-size:7.0pt;line-height:normal"> </span></span><span style="font-size:10.0pt;color:#262626">Develop and monitor systems to ensure the efficient and effective operation of the department</span></span></li> <li style="text-indent:-0.25in;font-size:16.0pt;font-family:Calibri, sans-serif;color:#365f91;font-weight:normal"><span style="font-family:tahoma, arial, helvetica, sans-serif"><span style="font-size:10.0pt;color:#262626">·<span style="font-style:normal;font-weight:normal;font-size:7.0pt;line-height:normal"> </span></span><span style="font-size:10.0pt;color:#262626">Interact with internal customers at headquarters, laboratories, and plasmapheresis centers to ensure that licensing and certification needs are met in support of company objectives and regulatory compliance, as required </span></span></li> <li style="text-indent:-0.25in;font-size:16.0pt;font-family:Calibri, sans-serif;color:#365f91;font-weight:normal"><span style="font-family:tahoma, arial, helvetica, sans-serif"><span style="font-size:10.0pt;color:#262626">·<span style="font-style:normal;font-weight:normal;font-size:7.0pt;line-height:normal"> </span></span><span style="font-size:10.0pt;color:#262626">Ensure files of all correspondence and communications with regulatory agencies are maintained and communicated with the Leadership Team</span></span></li> <li style="text-indent:-0.25in;font-size:16.0pt;font-family:Calibri, sans-serif;color:#365f91;font-weight:normal"><span style="font-family:tahoma, arial, helvetica, sans-serif"><span style="font-size:10.0pt;color:#262626">·<span style="font-style:normal;font-weight:normal;font-size:7.0pt;line-height:normal"> </span></span><span style="font-size:10.0pt;color:#262626">Maintain up to date knowledge of current Monitor and communicate changes in regulatory requirements and communicate regularly with the Leadership Team.</span></span></li> <li style="text-indent:-0.25in;font-size:16.0pt;font-family:Calibri, sans-serif;color:#365f91;font-weight:normal"><span style="font-family:tahoma, arial, helvetica, sans-serif"><span style="font-size:10.0pt;color:#262626">·<span style="font-style:normal;font-weight:normal;font-size:7.0pt;line-height:normal"> </span></span><span style="font-size:10.0pt;color:#262626">Prepare and update departmental SOPs and train staff as required</span></span></li> </ul> <h1 style="margin:0.0in;font-size:16.0pt;font-family:Calibri, sans-serif;color:#365f91;font-weight:normal"> </h1> <h1 style="margin:0.0in;font-size:16.0pt;font-family:Calibri, sans-serif;color:#365f91;font-weight:normal"><span style="font-family:tahoma, arial, helvetica, sans-serif"><strong><u><span style="font-size:10.0pt;color:#262626">Additional Responsibilities:</span></u></strong></span></h1> <ul> <li style="text-indent:-0.25in;font-size:16.0pt;font-family:Calibri, sans-serif;color:#365f91;font-weight:normal"><span style="font-family:tahoma, arial, helvetica, sans-serif"><span style="font-size:10.0pt;color:#262626">·<span style="font-style:normal;font-weight:normal;font-size:7.0pt;line-height:normal"> </span></span><span style="font-size:10.0pt;color:#262626">Review governing federal, state, and county licensing regulations to determine actions necessary for compliance</span></span></li> <li style="text-indent:-0.25in;font-size:16.0pt;font-family:Calibri, sans-serif;color:#365f91;font-weight:normal"><span style="font-family:tahoma, arial, helvetica, sans-serif"><span style="font-size:10.0pt;color:#262626">·<span style="font-style:normal;font-weight:normal;font-size:7.0pt;line-height:normal"> </span></span><span style="font-size:10.0pt;color:#262626">Communicate with governing federal, state, and county regulatory agencies to obtain clarification regarding regulatory requirements</span></span></li> <li style="text-indent:-0.25in;font-size:16.0pt;font-family:Calibri, sans-serif;color:#365f91;font-weight:normal"><span style="font-family:tahoma, arial, helvetica, sans-serif"><span style="font-size:10.0pt;color:#262626">·<span style="font-style:normal;font-weight:normal;font-size:7.0pt;line-height:normal"> </span></span><span style="font-size:10.0pt;color:#262626">Assess impact of business changes on licensing and or certification requirements</span></span></li> <li style="text-indent:-0.25in;font-size:16.0pt;font-family:Calibri, sans-serif;color:#365f91;font-weight:normal"><span style="font-family:tahoma, arial, helvetica, sans-serif"><span style="font-size:10.0pt;color:#262626">·<span style="font-style:normal;font-weight:normal;font-size:7.0pt;line-height:normal"> </span></span><span style="font-size:10.0pt;color:#262626">Track submission licensing and certification applications and renewals, monitor status, and provide regular status updates </span></span></li> <li style="text-indent:-0.25in;font-size:16.0pt;font-family:Calibri, sans-serif;color:#365f91;font-weight:normal"><span style="font-family:tahoma, arial, helvetica, sans-serif"><span style="font-size:10.0pt;color:#262626">·<span style="font-style:normal;font-weight:normal;font-size:7.0pt;line-height:normal"> </span></span><span style="font-size:10.0pt;color:#262626">File and archive submissions electronically and in hardcopy, share all relevant correspondence with the Leadership Team and necessary impacted areas plasmapheresis center and other interested parties</span></span></li> <li style="text-indent:-0.25in;font-size:16.0pt;font-family:Calibri, sans-serif;color:#365f91;font-weight:normal"><span style="font-family:tahoma, arial, helvetica, sans-serif"><span style="font-size:10.0pt;color:#262626">·<span style="font-style:normal;font-weight:normal;font-size:7.0pt;line-height:normal"> </span></span><span style="font-size:10.0pt;color:#262626">Perform other duties as required</span></span></li> </ul> <h1 style="margin:0.0in;font-size:16.0pt;font-family:Calibri, sans-serif;color:#365f91;font-weight:normal"><span style="font-family:tahoma, arial, helvetica, sans-serif"><strong><u><span style="font-size:10.0pt;color:#262626">Knowledge, Skills, and Abilities:</span></u></strong></span></h1> <ul> <li style="text-indent:-0.25in;font-size:16.0pt;font-family:Calibri, sans-serif;color:#365f91;font-weight:normal"><span style="font-family:tahoma, arial, helvetica, sans-serif"><span style="font-size:10.0pt;color:#262626">·<span style="font-style:normal;font-weight:normal;font-size:7.0pt;line-height:normal"> </span></span><span style="font-size:10.0pt;color:#262626">Knowledgeable of U.S. state, federal regulations, international and requirements pertaining to facility and laboratory licensing and certification.</span></span></li> <li style="text-indent:-0.25in;font-size:16.0pt;font-family:Calibri, sans-serif;color:#365f91;font-weight:normal"><span style="font-family:tahoma, arial, helvetica, sans-serif"><span style="font-size:10.0pt;color:#262626">·<span style="font-style:normal;font-weight:normal;font-size:7.0pt;line-height:normal"> </span></span><span style="font-size:10.0pt;color:#262626">Ability to work independently and initiate contacts as necessary</span></span></li> <li style="text-indent:-0.25in;font-size:16.0pt;font-family:Calibri, sans-serif;color:#365f91;font-weight:normal"><span style="font-family:tahoma, arial, helvetica, sans-serif"><span style="font-size:10.0pt;color:#262626">·<span style="font-style:normal;font-weight:normal;font-size:7.0pt;line-height:normal"> </span></span><span style="font-size:10.0pt;color:#262626">Ability to work as part of the regulatory team to meet group objectives </span></span></li> <li style="text-indent:-0.25in;font-size:16.0pt;font-family:Calibri, sans-serif;color:#365f91;font-weight:normal"><span style="font-family:tahoma, arial, helvetica, sans-serif"><span style="font-size:10.0pt;color:#262626">·<span style="font-style:normal;font-weight:normal;font-size:7.0pt;line-height:normal"> </span></span><span style="font-size:10.0pt;color:#262626">Ability to review a document in detail to ensure accuracy based on regulatory requirements, and to ensure the use of the appropriate forms, format, content, and authorized signatures </span></span></li> <li style="text-indent:-0.25in;font-size:16.0pt;font-family:Calibri, sans-serif;color:#365f91;font-weight:normal"><span style="font-family:tahoma, arial, helvetica, sans-serif"><span style="font-size:10.0pt;color:#262626">·<span style="font-style:normal;font-weight:normal;font-size:7.0pt;line-height:normal"> </span></span><span style="font-size:10.0pt;color:#262626">Ability to clearly communicate verbally and in writing with external contacts that may include, industry representatives, regulatory authorities at the federal, state, and local levels, as well as internal customers at headquarters and the plasmapheresis centers</span></span></li> <li style="text-indent:-0.25in;font-size:16.0pt;font-family:Calibri, sans-serif;color:#365f91;font-weight:normal"><span style="font-family:tahoma, arial, helvetica, sans-serif"><span style="font-size:10.0pt;color:#262626">·<span style="font-style:normal;font-weight:normal;font-size:7.0pt;line-height:normal"> </span></span><span style="font-size:10.0pt;color:#262626">Ability to effectively use Microsoft Office (particularly Word and Excel) as well as Adobe Acrobat to create, edit, and format and approve documents</span></span></li> <li style="text-indent:-0.25in;font-size:16.0pt;font-family:Calibri, sans-serif;color:#365f91;font-weight:normal"><span style="font-family:tahoma, arial, helvetica, sans-serif"><span style="font-size:10.0pt;color:#262626">·<span style="font-style:normal;font-weight:normal;font-size:7.0pt;line-height:normal"> </span></span><span style="font-size:10.0pt;color:#262626">Ability to interpret and effectively communicate regulatory requirements </span></span></li> <li style="text-indent:-0.25in;font-size:16.0pt;font-family:Calibri, sans-serif;color:#365f91;font-weight:normal"><span style="font-family:tahoma, arial, helvetica, sans-serif"><span style="font-size:10.0pt;color:#262626">·<span style="font-style:normal;font-weight:normal;font-size:7.0pt;line-height:normal"> </span></span><span style="font-size:10.0pt;color:#262626">Ability to successfully interact with regulatory agencies through professional, articulate, and courteous conversations and clear, concise written communications </span></span></li> <li style="text-indent:-0.25in;font-size:16.0pt;font-family:Calibri, sans-serif;color:#365f91;font-weight:normal"><span style="font-family:tahoma, arial, helvetica, sans-serif"><span style="font-size:10.0pt;color:#262626">·<span style="font-style:normal;font-weight:normal;font-size:7.0pt;line-height:normal"> </span></span><span style="font-size:10.0pt;color:#262626">Ability to meet statutory deadlines to ensure compliance, as well as business timelines to accomplish company objectives</span></span></li> </ul> <h1 style="margin:0.0in;font-size:16.0pt;font-family:Calibri, sans-serif;color:#365f91;font-weight:normal"><span style="font-family:tahoma, arial, helvetica, sans-serif"><strong><u><span style="font-size:10.0pt;color:#262626">Education and Experience:</span></u></strong></span></h1> <ul> <li style="text-indent:-0.25in;font-size:16.0pt;font-family:Calibri, sans-serif;color:#365f91;font-weight:normal"><span style="font-family:tahoma, arial, helvetica, sans-serif"><span style="font-size:10.0pt;color:#262626">·<span style="font-style:normal;font-weight:normal;font-size:7.0pt;line-height:normal"> </span></span><span style="font-size:10.0pt;color:#262626">Bachelor’s degree in a relevant discipline</span></span></li> <li style="text-indent:-0.25in;font-size:16.0pt;font-family:Calibri, sans-serif;color:#365f91;font-weight:normal"><span style="font-family:tahoma, arial, helvetica, sans-serif"><span style="font-size:10.0pt;color:#262626">·<span style="font-style:normal;font-weight:normal;font-size:7.0pt;line-height:normal"> </span></span><span style="font-size:10.0pt;color:#262626">5+ years of related technical and/or regulatory experience in pharmaceutical or blood industry or an equivalent combination of education and experience</span></span></li> </ul> <p style="text-indent:-0.25in;font-size:16.0pt;font-family:Calibri, sans-serif;color:#365f91;font-weight:normal"><span style="font-family:tahoma, arial, helvetica, sans-serif"><span style="font-size:10.0pt;color:#262626">#BiomatUSA</span></span></p> <p style="text-indent:-0.25in;font-size:16.0pt;font-family:Calibri, sans-serif;color:#365f91;font-weight:normal"><span style="font-family:tahoma, arial, helvetica, sans-serif"><span style="font-size:10.0pt;color:#262626">#LI-RL1</span></span></p> <p style="text-indent:-0.25in;font-size:16.0pt;font-family:Calibri, sans-serif;color:#365f91;font-weight:normal"><span style="font-family:tahoma, arial, helvetica, sans-serif"><span style="font-size:10.0pt;color:#262626">#LI-Hybrid</span></span></p><p style="margin-bottom:11.0px"><span style="font-size:10.0pt">The estimated pay scale for the Manager, Regulatory Affairs role based in California, is $131,363 - $197,046 per year. Additionally, the position is eligible to participate in up to 15% of the company bonus pool. We offer a wide variety of benefits including, but not limited to: Medical, Dental, Vision, life insurance, PTO, paid holidays and up to 5% 401(K) match and tuition reimbursement. Final compensation packages will ultimately depend on education, experience, skillset, knowledge, where the role is performed, internal equity and market data. We are committed to offering our employees opportunities for professional growth and career progression. Grifols is a global healthcare organization with employees in 30 countries focused on patient health and providing impactful results. Since our humble beginnings in 1909, Grifols has been a family company that prides itself on its family-like culture. Our company has more than tripled over the last 10 years, and you can grow with us! </span></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"><span style="font-size:11.0pt"><span style="font-family:Calibri, sans-serif"><strong>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, including but not limited to, the California Fair Chance Act, the Los Angeles County Fair Chance Ordinance for Employers, and the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.</strong></span></span></p> <p><a title="" href="https://www.grifols.com/documents/6155530/6442049/California_Personnel_Privacy_Policy.pdf/b39b908a-5cb6-7332-6c7b-8366abf087bf?t=1712755347369" target="_self">California Personnel Privacy Policy and Notice at Collection</a></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 : CA-Vista:USVISTA2 - Vista CA-980 Park Center Drive-AC</strong></p> <p><a href="https://www.grifols.com/en/what-we-do" target="_blank" rel="noopener">Learn more about Grifols</a></p> <p> </p>