Regulatory Affairs Specialist I/Sr. Regulatory Affairs Specialist I - NC-Clayton, United States - GRIFOLS, S.A.

Description

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. 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. This position is to support the Renewals for North America Biopharma industrial facilities (GT and GB). In addition, this position will manage Annual Reports and other duties as needed.

Primary responsibilities for the Regulatory Affairs Specialist role:

• Manages dossier compilation for product license renewals and other 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 registration dossiers, renewal applications and life-cycle management submissions (supplements, variations, amendments) for all regions for assigned products/projects.
• 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 translations, legalizations and apostilled documents with vendors for all North America regulatory affairs.
• Coordinates all Annual Reports of Minor Changes for products manufactured at GT and GB within the established timelines set forth by FDA.
• Request CPPs and CFGs electronically from FDA.
• 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 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.
• Manages translations, legalizations and apostilled documents with vendors for all North America regulatory affairs.
• Coordinates all Annual Reports of Minor Changes for products manufactured at GT and GB within the established timelines set forth by FDA.
• Request CPPs and CFGs electronically from FDA.
• 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.

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 may include industry representatives, regulatory authorities at the federal, state, and local levels.

Requirements:

Regulatory Affairs Specialist I

• Bachelor's degree in relevant discipline, or equivalent work experience.
• Minimum 2 years of related technical and/or regulatory experience in biopharmaceutical industry.

Sr. Regulatory Affairs Specialist I

• Bachelor's degree in relevant discipline, or equivalent work experience.
• Minimum 4 years of related technical and/or regulatory experience in biopharmaceutical 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.

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.

Occupational demands:

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.

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, including those with Criminal Histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.

Location: NORTH AMERICA : USA : NC-Clayton:USNC0002 - Clayton

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