Manager, Regulatory Affairs

Select how often (in days) to receive an alert: Create Alert 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. This position is based out of Vista, CA on a Hybrid Remote schedule. Summary: 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. Primary Responsibilities: Responsible for the operation of the Regulatory Affairs Department Responsible for management of Customer Complaints, Supplier Corrective Action Requests (SCAR), Quality Agreements, Supplier Quality, including customer questionnaires and feedback. Interact and support the control of Customer Specifications Assign work, monitor progress and quality of work so that work is equitably and appropriately assigned and deadlines are met with high quality work 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 Develop and monitor systems to ensure the efficient and effective operation of the department 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 Ensure files of all correspondence and communications with regulatory agencies are maintained and communicated with the Leadership Team Maintain up to date knowledge of current Monitor and communicate changes in regulatory requirements and communicate regularly with the Leadership Team. Prepare and update departmental SOPs and train staff as required Additional Responsibilities: Review governing federal, state, and county licensing regulations to determine actions necessary for compliance Communicate with governing federal, state, and county regulatory agencies to obtain clarification regarding regulatory requirements Assess impact of business changes on licensing and or certification requirements Track submission licensing and certification applications and renewals, monitor status, and provide regular status updates 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 Perform other duties as required Knowledge, Skills, and Abilities: Knowledgeable of U.S. state, federal regulations, international and requirements pertaining to facility and laboratory licensing and certification. Ability to work independently and initiate contacts as necessary Ability to work as part of the regulatory team to meet group objectives 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 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 Ability to effectively use Microsoft Office (particularly Word and Excel) as well as Adobe Acrobat to create, edit, and format and approve documents Ability to interpret and effectively communicate regulatory requirements Ability to successfully interact with regulatory agencies through professional, articulate, and courteous conversations and clear, concise written communications Ability to meet statutory deadlines to ensure compliance, as well as business timelines to accomplish company objectives Education and Experience: Bachelor’s degree in a relevant discipline 5+ years of related technical and/or regulatory experience in pharmaceutical or blood industry or an equivalent combination of education and experience #BiomatUSA #LI-RL1 #LI-Hybrid 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! 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. #J-18808-Ljbffr