Regulatory Affairs Specialist
hace 4 días
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. Role Mission Responsible for supporting document management, preparation, submission, and follow-up of registration and/or renewal files and/or changes/variations, as well as any other regulatory documentation, under his/her responsibility and within the established deadlines. 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. Represent the regulatory function on project teams as related to worldwide product registrations. 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 procedures. Who 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 Life Sciences field. Preferably 2 years of related technical and/or regulatory experience in pharmaceutical industry or an equivalent combination of education and experience. Highly valuable to have experience with applicable worldwide regulatory product registrations laws and regulations. Highly valuable experience of eCTD/CTD submissions, and dossier lifecycle management. Advanced level of English. User of Microsoft Office tools. You are meticulous and detail-oriented. You have excellent communication and teamwork skills, as well as initiative and results orientation. What we offer It is a brilliant opportunity for you, Grifols is fully aware that its employees are one of its major assets. We are committed to maintaining an atmosphere that encourages all our employees to develop their professional careers in an excellent working environment. Information about Grifols is available at . If you are interested in joining our company and you have what it takes for such an exciting position, then don’t hesitate to apply We look forward to receiving your application We believe in diverse talent and want to remove any barriers that may hinder your participation. If you require any adjustments in our selection process, please do not hesitate to inform us when applying. We are here to help.
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