Manager, Regulatory Affairs

Primary Responsibilities

• Responsible for the operation of the Regulatory Affairs Department
• Oversee facility licensing and certification (i.e., FDA, EU, PPTA IQPP, CLIA/COLA, AAB, State) activities for all Grifols BioSupplies Inc, ensuring that licenses and certificates, as applicable, are obtained and renewed within required time frames
• Interact and support the control of Customer Complaints, Supplier Corrective Action Requests (SCAR), Quality Agreements, Supplier Quality, including customer questionnaires and feedback
• Assign and monitor work to ensure deadlines are met with high quality work
• 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
• Maintain up to date knowledge of current 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
• 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

Pay

The estimated pay scale for the Manager, Regulatory Affairs role based in California, is $131,363 - $197,046 per year.

Benefits

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