Manager, Regulatory Affairs

Grifols

Manager of Regulatory Affairs overseeing facility licensing and certification at Grifols, ensuring compliance with regulatory requirements and support of company objectives.

Posted 5/11/2026full-timeVista • California • 🇺🇸 United StatesMid-LevelSenior💰 $131,363 - $197,046 per yearWebsite

About the role

Key responsibilities & impact

Responsible for the operation of the Regulatory Affairs Department
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, State) activities for all Grifols plasma companies
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
Ensure files of all correspondence and communications with regulatory agencies are maintained
Monitor and communicate changes in regulatory requirements
Prepare departmental SOPs and train staff as required
Review federal, state, and county licensing regulations to determine actions necessary for compliance
Communicate with federal, state, and county regulatory agencies to obtain clarification regarding regulatory requirements
Assess impact of business changes on licensing requirements
Track submission licensing applications and renewals, monitor status, and provide regular status updates
File and archive submissions electronically and in hardcopy, share all relevant correspondence with the plasmapheresis center and other interested parties
Perform other duties as required

Requirements

What you’ll need

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
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
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) to create, edit, and format 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

Benefits

Comp & perks

Medical
Dental
Vision
life insurance
PTO
paid holidays
up to 5% 401(K) match
tuition reimbursement

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

regulatory compliancefacility licensingcertificationSOP developmentdocument reviewsubmission trackingregulatory requirements interpretationquality monitoringtechnical experienceregulatory documentation

Soft Skills

independent workteam collaborationdetail-orientedverbal communicationwritten communicationinterpersonal skillsinitiativecourtesyclaritytime management