Reg Affairs Specialist I/Sr. Reg Affairs Specialist I

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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 role is responsible for the compilation and submission of regulatory documentation to global Health Agencies in electronic and/or paper formats, in accordance with agency requirements and company timelines.  Responsible for individual global projects/submissions and ensures management of regulatory information utilizing business systems and processes.  Determine and execute actions necessary for new licenses and license supplements to ensure that Grifols complies with domestic and international licensing requirements and business objectives are met. 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.

 

Primary responsibilities for the Regulatory Affairs Specialist role:

• Manages dossier compilation for projects or assigned product(s) in accordance with RA timelines to meet global registration objectives worldwide.  Tracks and updates management regarding regulatory submission deliverables.
• Assembles, formats, and archives Regulatory registration dossiers/product development applications (e.g. BLAs, MAAs, NDSs, NDAs, PMAs, 510(k)s, etc.), and life-cycle management submissions (supplements, variations, amendments) for all regions for GT products or others as required. 
• Ensures compliance with regulatory agency rules and guidelines for paper and electronic submissions.  Provides update to internal documentation, as appropriate.
• Responsible for data maintenance regarding submissions in the regulatory tracking database for all regions.
• Perform other duties as required.

 

Primary responsibilities for the Regulatory Affairs Senior Specialist role:

• Act as Regulatory Affairs representative for specified key projects/products/facilities/equipment.
• Prepare complex submissions to worldwide governmental agencies and ensure contents complies with domestic and international regulatory requirements.
• Prepare recurrent and routinely requested data, listing, and notifications for assigned projects for submission to regulatory agencies.
• Prepare official submissions to regulatory agencies for new or modified products.
• Prepare 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.
• Inform other departments on new regulatory developments.
• Research regulations and guidelines and interact with domestic and international regulatory affiliates/distributors to provide effective regulatory assessment of proposed changes to products/facilities/equipment.
• Responsible for data maintenance regarding submissions in the regulatory tracking database for all regions.
• Perform other duties as required.

 

Additional Responsibilities:

Manage and prioritize multiple and possibly conflicting complex projects, timelines, and objectives within a matrix team environment.  Compile comprehensive scientific information for use in regulatory submissions. Ability to collaborate with cross functional teams to meet business objectives. Review a document in detail to ensure technical accuracy and compliance with regulatory requirements.

 

Preferred Skills / Knowledge:

• Ideally should have regulatory experience.
• Flexible and adaptable to changing situations/projects within the company/industry
• Basic knowledge of applicable laws and regulations.
• Ability to work under tight timelines to meet deadlines and business objectives.
• Superior skills with the use of MS-Office and ability to learn Regulatory specific software/electronic systems.  
• Ability to work independently with limited supervision.
• High degree of attention to detail and troubleshooting skills.
• Knowledge of global health agency submissions requirements (CTD/eCTD).
• 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