Grifols Jobs

Job Information

Grifols Shared Services North America, Inc Regulatory Affairs Specialist / Regulatory Affairs Senior Specialist in Clayton, North Carolina

For more than 75 years, Grifols has worked to improve the health and well-being of people around the world. We are a global healthcare company that produces essential plasma-derived medicines for patients and provides hospitals and healthcare professionals with the tools, information and services they need to deliver expert medical care.

Regulatory Affairs Specialist / Regulatory Affairs Senior Specialist

This position is specific to the Regulatory Operations function of Regulatory Affairs. This includes but is not limited to electronic publishing, RSD processing and maintaining license history for GT products.

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 is in compliance 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:

  • 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) for all regions for GT products.

  • 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.

  • 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.

*Prepares documentation for submissions including e-submission readiness, document processing and lifecycle/version management.

Primary responsibilities for the Regulatory Affairs Senior Specialist role:

  • 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) for all regions for GT products.

*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.

  • Responsible for data maintenance regarding submissions in the regulatory tracking database for all regions.

  • Assemble/format submissions in such a manner to facilitate the review process.

  • Prepare documentation for submissions including e-submission readiness, document processing and lifecycle/version management

*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:

• Ability to work under tight timelines to meet deadlines and business objectives.

• Knowledge of global health agency submissions requirements (CTD/eCTD).

• Ideally should have regulatory experience.

• Flexible and adaptable to changing situations/projects within the company/industry • Basic knowledge of applicable laws and regulations.

• 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.

• Proficient in MSWord, Excel, and Adobe.

• Ability to work as part of the regulatory team to meet group objectives

Salary Grade: M06 / M08

Requirements:

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.

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.

EEO Minorities/Women/Disabled/Veterans

Location: [[mfield6]] : [[cust_building]]

Learn more about Grifols at http://www.grifols.com/es/web/international/home

Req ID: 79889

Type: Regular Full-Time

Job Category: Regulatory Affairs

DirectEmployers