Biopharma Regulatory Affairs Specialist
hace 4 semanas
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.
We believe that diversity adds value to our business, our teams and our culture. We are committed to equal employment opportunities that foster an inclusive environment.
Help us lead one of the world’s largest pharmaceutical companies. We are a world leader in plasma-derived medicines with a presence in more than 100 countries, and a growing global team of over 20.000 people. That’s why we need a Regulatory Affairs Specialist like you.
Mission
Prepare, review, and manage complex submissions and follow up of product registrations or any other regulatory activity, ensuring timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.
Maintain tracking of product registrations.
What your responsibilities will be
Prepare, review, and manage complex submissions and follow up of product registrations or any other regulatory activity, ensuring timeliness, accuracy, comprehensiveness, or compliance with regulatory standards. Communicate with affiliates, outside companies and Health Authorities for specific projects. Represent the regulatory function on project teams as related to worldwide product registrations. Collaborate with cross-functional subject matter experts to identify documentation to support regulatory submissions. Adapt licenses to current regulations. Maintain tracking of product registrations. Support other Departments, Affiliates and Third Parties in any required regulatory information. Create Regulatory Affairs policies and proceduresWho you are
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, education, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions).
Bachelor's degree in relevant discipline: Experimental and Health Sciences. Minimum 2 years of related technical and/or regulatory experience in pharmaceutical industry or an equivalent combination of education and experience. Fluent written and spoken English (C1 Advanced) and Spanish. Experience of eCTD/CTD submissions, and dossier lifecycle management. Flexible and adaptable to changing situations/projects within the company/industry. Ability to work under tight timelines to meet deadlines and business objectives. Ability to work with limited supervision and initiate contacts essential to submission preparation. Ability to work as part of the regulatory team to meet the objectives. High degree of attention to detail and troubleshooting skills. Analytical skills and ability to summarize. Ability to clearly communicate verbally and in writing. Ability to research regulatory requirements. Computer skills (such as MS Office, databases, Document Management System).What we offer
It’s a brilliant opportunity for someone with the right talents.
Grifols understands you want a challenging and rewarding career in a critical function such as Regulatory Affairs Specialist help you grow professionally.
Information about Grifols is available at . If you’re interested in joining our company and you have what it takes, then don’t hesitate to apply.
We look forward to receiving your application.
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