Job: Regulatory Affairs Specialist / Senior - Spanish Speaking, Grifols, Clayton, NC
Fluency in Spanish is Required
Regulatory Affairs Specialist / Regulatory Affairs Senior Specialist
This role is responsible for the compilation and submission of regulatory documentation to global Health Agencies, 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 is in compliance with domestic and international licensing requirements and business objectives are met. Process, compile, submit, and maintain documentation for global regulatory submissions to global Health Agencies 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 (eg BLAs, MAAs, NDSs, NDAs, PMAs, 510(k)s, INDs/CTAs, Orphan Drug Applications, etc), and life-cycle management submissions (supplements, variations, amendments) globally for bioscience products. Ensures compliance with regulatory agency rules and guidelines for submissions; Provides update to internal documentation, as appropriate. Responsible for data maintenance regarding submissions in the regulatory tracking database for all regions.
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 are in compliance 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 and responses to 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 including but not limited to submission contents and approvals and new guidance requirements. 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.
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
Fluency in Spanish is REQUIRED. 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. 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 successfully interact with regulatory agencies through professional, articulate, and courteous conversations and clear, concise written communications.
Fluency in Spanish is Required.
Regulatory Affairs Specialist: Bachelor’s degree in relevant discipline, or equivalent work experience. Plus 2 years of related technical and/or related experience in the biopharmaceutical industry.
Regulatory Affairs Senior Specialist: Bachelor’s degree in relevant discipline, or equivalent work experience / industry regulatory experience. Plus a 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. Knowledge of applicable laws and regulations. Proficient with Microsoft Office (particularly Word).
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. 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.