Manager, Regulatory Affairs

GRIFOLS, S.A.•Oceanside, CA

2d•Onsite

About The Position

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.

Requirements

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) to create, edit, and format documents
Ability to interpret and effectively communicate regulatory requirements
Ability to meet statutory deadlines to ensure compliance, as well as business timelines to accomplish company objectives

Nice To Haves

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

Responsibilities

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, ensuring that licenses and certificates 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
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