Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

　　Summary

　　Maintains regulatory documentation and filing systems in support of the Biopharma North America regulatory team. Maintains accurate files of health authority correspondence in paper and electronic formats as needed and word processing submission documents as needed. This position will support the product managers to meet business objectives for the overall regulatory team.

　　Primary Responsibilities

　　Perform updates, facilitate SME reviews, and ensure proper hard copy and electronic filing of Regulatory Submission Documents (RSDs) as needed.

　　Ensure that regulatory records are properly filed and accessible in the appropriate documentation system.

　　Assist in maintaining SOPs/IBPs that describe the Regulatory Affairs filing system and other RA SOPs/IBPs files and maintenance.

　　Manage requests for translations and legalizations with vendors.

　　Respond to requests for records by researching and reviewing internal documentation, including the retrieval of documents from off-site storage.

　　Communicate with regulatory personnel regarding regulatory records.

　　Process and track all invoices to ensure prompt payment.

　　Request Certificate of Foreign Governments (CFG) and Certificate of Pharmaceutical Products (CPP) from FDA

　　Serve as primary contact with Accounts Payable.

　　Note: This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Manager and supervisors may assign other duties as needed.

　　Knowledge, Skills, and Abilities

　　Basic knowledge of applicable laws and regulations.

　　Ability to work with limited supervision and initiate contacts essential to submission preparation.

　　Ability to manage multiple and possibly conflicting priorities.

　　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.

　　Ability to effectively use Microsoft Office (particularly Word and Excel) to create, edit, and format documents.

　　Ability to work with other computer systems for filing supplements and reports.

　　Ability to meet statutory deadlines to ensure compliance, as well as business timelines to accomplish company objectives.

　　Education

　　Bachelor’s degree in a relevant discipline, or equivalent work experience.

　　Experience

　　0 to 1 year of related technical and/or regulatory experience in pharmaceutical or blood industry or an equivalent combination of education and experience.

　　Equivalency

　　Depending on 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 requires a Bachelors degree plus 4 years experience, an equivalency could include 8 years, an Associates degree with 6 years experience, or Master's or a Master's degree with 2 years experience.

　　Third Party Agency and Recruiter Notice:

　　Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.

　　Grifols provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other characteristic or status protected by law. 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.

　　Learn more about Grifols (https://www.grifols.com/en/what-we-do)

　　Req ID: 509910

　　Type: Regular Full-Time

　　Job Category: Regulatory Affairs