Grifols Shared Services North America, Inc Administrative Assistant IV in Emeryville, California
Do you want to join an international team working to improve the future of healthcare? Do you want to improve the lives of millions of people? Grifols is a global healthcare company which, since its foundation in Barcelona in 1909, has been working to improve the health and well-being of people all over the world. Our four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative medicines, solutions and services in more than 100 countries and regions.
Responsible for tasks related to the maintenance of regulatory records (paper and/or electronic). Responsible for electronic publishing and submission of regulatory applications/dossiers and other regulatory correspondence as necessary to comply with eCTD or other electronic submissions requirements. Provides support to the Regulatory Affairs Department to ensure that deadlines and business objectives are met.
Primary responsibilities for role:
●Formats/publishes electronic and paper submissions such as BLAs/NDAs/ANDAs, supplements and amendments, INDs, 510(k)s, and labeling.
●Tracks records and submissions using electronic tools and systems such as spreadsheets, databases, and Electronic Submissions Gateway(ESG) to monitor the status of regulatory submissions
●Maintains (files and archives) electronic and hard copy regulatory records (e.g., submissions, certificates, licenses) to ensure that they are accessible and comply with regulatory authority and corporate record retention requirements and policies
●Acts as the point of contact with regulatory authorities, industry organizations, and vendors when information is needed on formats, procedures or other pertinent issues related to electronic and paper records (e.g., submissions, Structured Product Labeling, certificates, licenses).
●Manages records for off-site storage (e.g., index, box, ship)
●Maintains the annual Blood Establishment Registration, Drug Establishment and Listing and Device Establishment Registration and Listing, as required, depending on portfolio of products within the supported organizations (Grifols Plasma Operations, BioScience, Diagnostics/Devices and/or Hospital Products)
●Provides administrative support to the RA staff that includes (but is not limited to) processing regulatory invoices, ordering office supplies, photocopying, notary public duties, travel coordination, along with assisting with requests for FDA certificates, embassy legalization of documents, etc.
●Performs other duties as required.
Ability to work with limited supervision and independently, and as part of the regulatory team.
Excellent written and verbal communication skills.
Good organizational and time management skills plus good decision making ability.
Must be proficient in Word, Excel, Adobe Acrobat, Power Point and Access.
Must be flexible and adaptable to frequent interruptions and tight schedules.
Ability to meet deadlines to ensure compliance with internal timeliness/schedules to meet company objectives.
Maintains (files and archives) electronic and hard copy regulatory records (submissions, certificates, licenses) to ensure that they are accessible and comply with regulatory authorities
Responsible for the maintenance of regulatory records (paper and electronic) as well as electronic publishing to health authorities.
Minimum of an associate degree, or equivalent work experience.
Minimum 0-2 years of related technical and/or regulatory experience in pharmaceutical regulated industry or an equivalent combination of education and experience.
Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirement.
Example: If a job level typically requires an Associate’s degree plus 2 years of experience, am equivalent could include 4 years of experience or a Bachelor’s degree.
- May occasionally lift, carry, push, pull or otherwise manipulate objects up to 25 pounds in weight, and/or lift, carry, push, pull or otherwise manipulate objects up to 10 pounds in weight frequently or continuously.
EEO Minorities/ Disability/Veterans
Grifols is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and local laws that prohibit employment discrimination on the basis of race, color, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability or veteran's status or any other classification protected by applicable State/Federal laws. We will consider for employment all qualified Applicants, including those with Criminal Histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.
Req ID: 278209