Regulatory Affairs Senior Specialist page is loaded## Regulatory Affairs Senior Specialistlocations: Inverin, County Galway, Irelandtime type: Temps pleinposted on: Offre publiée aujourd'huijob requisition id: R5662653Mylan TeorantaChez Viatris, nous envisageons la santé non pas telle qu'elle est mais telle qu'elle devrait être. Nous agissons avec courage et notre positionnement unique est source de stabilité dans un monde où les besoins en matière de santé sont en constante évolution. Viatris permet à chacun dans le monde entier de vivre en meilleure santé à chaque étape de sa vie. Via trois axes majeurs:*Accès*: En fournissant des médicaments de haute qualité et reconnus, quels que soient le lieu de résidence ou la situation de chaque patient.*Leadership*: En favorisant l’évolution de nos activités de façon durable et le développement de solutions innovantes pour améliorer la santé des patients.*Partenariat*: En valorisant notre expertise collective afin de donner accès à tous à nos produits et services.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**Every day, we rise to the challenge to make a difference and here’s how the **Regulatory Affairs Senior Specialist** role will make an impact:* Life cycle management and regulatory filing maintenance activities; + Preparation, review and submission of FDA required Annual Reports for (Abbreviated) New Drug Applications including scheduling and coordinating receipt of documentation/information, preparing cover letters, describing changes made to the application, and tracking progress of their preparation. This also includes the review of documents, and utilizing the change control database to ensure accurate reporting and tracking FDA acknowledgements. Failure to prepare accurate and timely Annual Reports could result in FDA action which may include the removal of products from the marketplace. Assess and review documentation to ensure compliance with product licences. + Preparation, review and submission of amendments and supplements/variations to product marketing applications. + Provide departmental management regulatory guidance and input to other departments (QA, QC, Manufacturing, etc.) for planned changes.* New Product Submission Activities; + Preparation of submission documentation, in eCTD format, for pharmaceutical products (including combination products) for approval by the US FDA, European Regulatory Authorities and worldwide, as required. + Monitoring the progress of regulatory submissions, responding to queries and ensuring that approvals are granted without undue delays. + Provide a critical detailed review of technical documentation, including but not limited to, analytical procedures, validation/verification reports, product specifications, manufacturing batch records, in-process specifications, drug substance information, device related information etc. prior to submission.* Assessment of change control documentation and recommend the appropriate regulatory reporting mechanism using Health Authority regulations, guidance documents and in-house policies and submit associated amendments / variations / supplements as required.* Establish and maintain positive working relationships with internal and external partners to facilitate efficient accomplishment of regulatory goals.* Actively participate in project teams, as required.* Research information pertaining to marketing applications through the navigation of existing submissions and associated comments and regulatory documentation system.* Maintain current knowledge of regulations and guidances as applicable to role by utilizing the Health Authority websites and attendance at conferences.**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:* Strong knowledge of the Regional Pharmacopoeia (Ph. Eur. & USP), Title 21 of the Code of Federal Regulations and various Health Authority Guidances for Industry (particularly those dealing with sterile products).* Knowledge of the regulatory process pertaining to drug development, registration, review and approval.* Knowledge of parenteral product submissions.* Experience in writing and submitting regulatory documentation.* Knowledge of cGMP awareness and compliance.* Knowledge of sterile products and their unique regulatory requirements.* Excellent communication skills, both oral and written.* Experience in writing and submitting regulatory documentation.* Ability to respond quickly to a changing regulatory environment.* Computer skills, E-mail (Outlook), Microsoft Word, Excel, Powerpoint, change management systems and documentation management systems an advantage.At Viatris, we are dedicated to building a truly diverse, inclusive and authentic workplace, so if you’re excited about this role but your past 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.**Benefits at Viatris**At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others. Some of our benefits include the following on top of a competitive salary:* Excellent career progression opportunities* Work-life balance initiatives* Bonus scheme* Health insurance* Pension**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 visitChez Viatris, nous proposons des salaires compétitifs, des bénéfices et un environnement inclusif au sein duquel vous pouvez mettre à profit votre expérience, vos perspectives et vos compétences pour aider à avoir un impact positif sur la vie des autres.Viatris est une entreprise mondiale de services de santé créée en 2020 par la combinaison de Mylan et Upjohn, une division héritée de Pfizer. En intégrant les atouts de ces deux entreprises, y compris notre main-d’œuvre mondiale d’environ 45 000 personnes, nous visons à offrir un accès accru à des médicaments abordables et de qualité pour les patients du monde entier, indépendamment de la géographie ou des circonstances. Nous croyons aux services de santé comme ils devraient l’être, permettant aux personnes du monde entier de vivre plus sainement à chaque étape de la vie. Et parce que nous croyons fermement qu’un meilleur accès aux soins conduit à une meilleure santé, nous réunissons des compétences scientifiques et logistiques d’excellence, ainsi que des expertises commerciales éprouvées pour fournir des médicaments de qualité aux patients, où et quand ils en ont besoin.
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