Generics [U.K.] Ltd.En VIATRIS, vemos la atención médica no como es, sino como debería de ser. Actuamos con valentía y estamos en una posición única para ser una fuente de estabilidad en un mundo de necesidades de atención médica en constante evolución.Viatris ayuda a las personas de todo el mundo a vivir de manera más saludable en cada etapa de la vida.Lo hacemos a través de:Acceso – suministrando medicamentos de confianza y de alta calidad independientemente de la geografía o las circunstancias;Liderazgo – promoviendo operaciones sostenibles y soluciones innovadoras para mejorar la salud del paciente;Our global portfolio includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. We are committed to helping create healthier communities worldwide through education, outreach and better access to treatment.For those driven to live their lives with purpose, Viatris helps employees realise their full potential by creating a collaborative culture that fosters courage and resilience. Viatris is more than just a place to work. This is a place to make a difference in the world.**The Role & What You Will Be Doing**Manager Corporate Drug Regulatory Affairs responsible to support the pharmaceutical-regulatory of the assigned medicinal products and products worldwide. The jobholder is bound to the instructions of the responsible Team leader of Corporate Drug Regulatory Affairs.**Key Responsibilities**Every day, we rise to the challenge to make a difference and here’s how the Manager Corporate Drug Regulatory Affairs role will make an impact:* Examination, preparation,coordination and processing of regulatory documents, pharmaceutical quality documentation (CTD – module 3), pharmaceutical development, manufacturing and quality control, pharmaceutical technology, pharmacological-toxicological documentation, as well as pharmaceutical expert reports,* Responsible for Risk-benefit-description for medicinal products with regard to pharmaceutical-pharmacological topics,* Coordination of clinical and non-clinical documentation with clinical research, medical information and drug safety,* Handling of marketing authorisation application procedures (new submissions, line extensions, variations) worldwide, as well as registration maintenance activities (eg variations, renewals),* Contact to authorites on national and international level,* Preparation and discussion of licensing strategies with national and international authorities,* Pharmaceutical-regulatory support and advice to other departments and business units (e.g.. of the Qualified Person acc. § 15 German Drug law) regarding pharmaceutical topics before / during / after approval at national and international level,* Support of QA activities (e.g. change control, PQR) and support of drug information/ labelling acitivies,* Support of pharmacovigilance related activities (e.g. Risk Management Plans, Company Core Data Sheets, PSURs),* Training of employees of the CDRA department with regard to pharmaceutical topics* Participation in the training and education of pharmacists (e.g. pharmacy students in the context of the third training section according to AAppO)**About Your Skills & Experience**For this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences:* Completed university degree in pharmacy, according to the approbation regulations for pharmacists (AAppO)).* Experience in regulatory affairs,* Knowledge of essential regulatory requirements globally,* Ability to plan and execute regulatory projects with special consideration of the pharmaceutical and pharmacological know-how,* Excellent communication skills, a real team player,* Ability to establish working contacts with authorities* Excellent skills in English language,* Knowledge in standard EDV programs (e.g. Word, Exel, Powerpoint).At Viatris, we are dedicated to building a truly diverse, inclusive and authentic workplace, so if you’re excited about this role but your experience doesn’t fully align with every requirement, we still encourage you to apply. You may just be the right candidate for this or other roles.**Diversity & Inclusion at Viatris**At Viatris, diversity and inclusion are essential to our mission. The diversity we foster in all aspects of our business can be one of our greatest strengths in redefining healthcare not as it is, but as it should be. If you would like to know more about what diversity, equity and inclusion means to us, please visit**Sustainability at Viatris**Corporate social responsibility is fundamental to the Viatris mission. We work to advance responsible and sustainable operations and leverage our collective expertise to empower people to live healthier at every stage of life, recognizing that our actions affect the stakeholders and communities we serve. To learn more about our efforts, please visitEn Viatris, ofrecemos salarios competitivos, beneficios y un entorno inclusivo donde puede usar sus experiencias, perspectivas y habilidades para ayudar a generar un impacto en la vida de los demás.Colaboración – aprovechando nuestra experiencia común para conectar a las personas con productos y servicios.Viatris es una compañía global del cuidado de la salud creada en 2020 a través de la combinación de Mylan y Upjohn, una división legada de Pfizer. Al integrar las fortalezas de estas dos compañías, incluida nuestra fuerza laboral global de aprox. 45,000, nuestro objetivo es proporcionar acceso mejorado a medicamentos de calidad asequibles a pacientes de todo el mundo, independientemente de dónde vivan o de las circunstancias. Creemos en el cuidado de la salud como debe ser: empoderamos a las personas de todo el mundo para que vivan de manera más saludable en cada etapa de la vida. Debido a nuestra creencia firme de que un acceso mejorado permite una mejor salud, aprovechamos nuestra experiencia científica y de manufactura inmejorable, al igual que las capacidades comerciales comprobadas, para ofrecer a los pacientes medicamentos de calidad en el momento y en el lugar que los necesiten.
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