Regulatory Affairs Specialist - Licensing

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.

This position is a hybrid work schedule based out of our RTP, NC office.

Summary:

Determine and execute actions necessary for BLA License supplements and other regulatory submissions to ensure that Grifols Plasma Operations is in compliance with federal, state, and local licensing and other regulatory requirements, and that business objectives are met.                                   

Primary Responsibilities:

• Compile and process regulatory submissions through coordination with other departments and research of internal documentation including: completing applications and forms; composing cover letters and summaries; assembling, formatting and packaging submissions in a manner to facilitate the review process; submitting and tracking submissions and providing updates on status; filing, archiving and distributing submissions electronically and in hardcopy.                          
• Communicate with agencies to monitor registration activity, obtain clarification regarding regulatory requirements, and discuss and determine strategies for regulatory filing            
• Assist in preparing responses to regulatory agency inquiries                                                                  
• Maintain files of all interactions with all agencies                                                                      
• Communicate with internal customers at headquarters and at the plasmapheresis centers regarding regulatory requirements                                                                  
• Perform other duties as required            

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 successfully interact with regulatory agencies through professional, articulate, and courteous conversations and clear, concise written communications
• 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 and tracking supplements and reports
• Ability to meet statutory deadlines to ensure compliance, as well as business timelines to accomplish company objectives

Education and Experience:

• Bachelor’s degree in relevant discipline, or equivalent work experience.                     
• 0-2 years of related technical and/or regulatory experience in pharmaceutical or blood 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 requirements.  Example:  If a job level requires a Bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Master’s degree with 2 years of experience.

This position is eligible to participate in up to 5% of the company bonus pool. We offer a wide variety of benefits including, but not limited to: Medical, Dental, Vision, PTO, up to 5% 401(K) match and tuition reimbursement. Final compensation packages will ultimately depend on education, experience, skillset, knowledge, where the role is performed, internal equity and market data. We are committed to offering our employees opportunities for professional growth and career progression. Grifols is a global healthcare organization with employees in 30 countries focused on patient health and providing impactful results. Since our humble beginnings in 1909, Grifols has been a family company that prides itself on its family-like culture. Our company has more than tripled over the last 10 years, and you can grow with us!

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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 in a manner consistent with the requirements of applicable state and local laws.

Location: NORTH AMERICA : USA : NC-RTP:USNC0001 - RTP NC-Headquarters 

Learn more about Grifols