Grifols Shared Services North America, Inc Manager, Regulatory Affairs - Licensing in Clayton, North Carolina
Manager, Regulatory Affairs-Licensing
The Manager, Regulatory Affairs - Licensing, is responsible for the operation of the Regulatory Affairs - Licensing Department. The position oversees facility licensing and certification activities (i.e., FDA, PPTA IQPP, CLIA/COLA, AAB, State) for all Grifols plasma companies, ensuring that licenses and certificates are obtained and renewed within required time frames. In addition, the Manager, Regulatory Affairs - Licensing, interacts 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.
● Responsible for the operation of the Regulatory Affairs - Licensing 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, 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
Knowledgeable of U.S. state and federal regulations 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 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
Bachelor’s Degree in a Relevant Discipline PLUS 5 years of related technical and / or Regulatory experience in Pharmaceutical or blood industry or an equivalent combination of education and experience.
Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Frequent hand movement of both hands with the ability to make fast, simple movements of the fingers, hands, and wrists. Occasionally walks. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Frequently drives to site locations with occasional travel within the United States. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Frequently interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues. Ability to apply abstract principles to solve complex conceptual issues.
Req ID: 185648