What are the responsibilities and job description for the Senior Regulatory Affairs Specialist position at GRIFOLS, S.A.?
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.
The purpose of this position to act as a team member in the product manager area of Regulatory Affairs (Biopharma) supporting global submissions for various areas of the business. This could include areas such as plasma related (PMF), facility related, or preparation of product specific submission packages to global health authorities to support business needs in a very timely and accurate manner.
Sr Reg Affairs Specialist I
Primary responsibilities for role :
- Act as Regulatory Affairs representative for specified key products / facilities / equipment.
- Prepare complex submissions to various 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.
- 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 counterparts to provide effective regulatory assessment of proposed changes to products / facilities / equipment.
- Perform other duties as required.
Additional Responsibilities, Knowledge, Skills and Abilities :
Requirements :
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.
Sr. Reg Affairs Specialist II
Primary responsibilities for role :
Additional Responsibilities, Knowledge, Skills and Abilities :
Requirements :
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.
This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.
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. 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 complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Frequently interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues. Ability to apply abstract principles to solve complex conceptual issues.
Work Location : Clayton, NC
Schedule : 1st shift / days. Position offers potential hybrid flexibility upon successful completion of required training.
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 in a manner consistent with the requirements of applicable state and local laws.
Location : NORTH AMERICA : USA : NC-Clayton : USNC0002 - Clayton
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