Grifols Shared Services North America, Inc Sr. Regulatory Affairs Specialist in Durham, North Carolina
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.
This position is in the R&D Regulatory Strategy Department. The successful candidate will work with R&D Regulatory Strategy and Clinical Development team members to prepare and submit complex clinical trial applications for Grifols clinical programs. They will also process, compile, submit, and maintain Regulatory Submission Documentation for global regulatory submissions to global Health Agencies in electronic and/or paper formats and in accordance with agency requirements and company timelines.
Act as Regulatory Operations expert for processing of all submissions related to clinical studies
Prepare complex submissions to various governmental agencies and ensure contents are in compliance with domestic and international regulatory requirements
Compile and submit responses to regulatory agency inquiries
Compile regulatory submissions through coordination with other departments and research of internal documentation, complete applications and forms, compose cover letters and summaries, assemble/format submissions in such a manner to facilitate the review process
Set up and maintain database of clinical trial-related submissions
Track and implement changes needed to the publishing and submission processes for regulatory agencies as required
Work with other Grifols Biopharma Regulatory Operations personnel to ensure consistency across submission processes
Knowledge, Skills, & Abilities:
Ability to work independently.
Ability to work as part of the regulatory team to meet group objectives
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.
Ability to effectively use Microsoft Office (particularly Word and Excel) to create, edit, and format documents
Ability to work with other computer / software systems as needed.
Ability to successfully interact with regulatory agencies through professional, articulate, and courteous conversations and clear, concise written communications.
May also require: Experience with electronic regulatory publishing and submissions software; superior skills with the use of MS-Word, Adobe Acrobat and Adobe plug-in tools; a high degree of attention to detail and troubleshooting skills; knowledge of global health agency submissions requirements (CTD/eCTD).
Ability to work under tight timelines to meet deadlines and business objectives.
Bachelor’s degree in relevant discipline, or equivalent work experience / industry regulatory experience.
Minimum 3 years of related technical and/or regulatory experience in pharmaceutical industry
Experience with the pre-clinical, clinical, chemistry, manufacturing, and controls of biological products and/or e-submissions and regulatory information management experience.
Knowledge of applicable laws and regulations.
Proficient with Microsoft Office (particularly Word).
Ideally should have e-submissions and regulatory information management 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 and stands. 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 information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues.
Req ID: 441168